Bad Medicine

3.6.22

By Mike Smith

On March 1, 2022, the US Food and Drug Administration issued a Class 1 recall of the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test because: “The test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.”

The FDA Class 1 recall notification states that the unauthorized SD Biosensor STANDARD Q COVID-19 Ag Home Test uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19.

The recalled product should not be confused with SD Biosensor’s approved at-home test, the SD Biosensor COVID-19 At-Home Test, authorized by the FDA on December 24, 2021, which is a different test and is not the subject of this Safety Communication. The authorized test is distributed by Roche and can continue to be used.

According to the FDA, there have been no reports of injuries, adverse health consequences, or death associated with use of the SD Biosensor STANDARD Q COVID-19 Ag Home Test.

12.7.20

By Mike Smith

In late November, Cook Medical began to recall lots of its Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers because of serious risk of injury from device separation when these arterial catheters are being used in surgical and diagnostic procedures. The FDA quickly categorized the action as a Class 1 recall
, which are the most serious and urgent type of recall.

According to the FDA, these catheters that have a coated shaft, a valve, a dilator, and markers that show up on an x-ray. The catheters help insert other medical devices used for therapy or diagnosis into the vessels, except those of the heart and brain, during surgery or other procedures.

These catheters have an increased chance of separation at a specific bonding point, which could prevent the completion of the intervention and create the very real danger of leaving a part of a medical product inside the patient.

According to the FDA:

• If the device separates during use, this may lead to life-threatening adverse events.
• Use of the affected product may cause serious adverse events, including longer procedure time, another procedure to take out a separated piece, blocking blood flow to vital organs, vessel injury, and bleeding.
• There have been 57 complaints about this device issue and 14 reports of serious injuries. There have been no reported deaths.

2020 has been a bad year for arterial catheters with many of the biggest manufacturers in this sector issuing Class I Recalls, many of which were linked to serious injuries and patient deaths. Like this Cook Medical recall, many of these others were due to deployment device failure. See posts here (Abbott Balloons fail to deflate), here (Pipeline Flex), here (SD Biosensor) and here (Stryker Deadly Recall) for more details on the long list of 2020 arterial catheter device recalls.

10.12.20

By Mike Smith

The FDA released details of the Class 1 recall of the Stryker Neurovascular Trevo XP ProVue Retriever because the core wire of the device can break and separate from the body of the device during surgery.

Stryker initiated the recall on September 21, according to the FDA. All told, 1,258 at-risk Trevo XP ProVue Retriever devices were being recalled. The company took this action in response to numerous incidents that lead to 11 reports of injury and one death.

The Trevo XP ProVue Retriever is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke. However, according to the FDA, the device proved unsafe and had to be recalled because “there is a risk the core wire may break or separate when the core wire is retracted during use. If this occurs, the device could be left inside the patient’s blood vessel or tissue. The use of affected devices may cause serious adverse health consequences, including bleeding, additional blockage of blood vessels, disability, and death.”

9.12.20

By Mike Smith

The Medtronic Rashkind Balloon Septostomy Catheter is designed to resolve an atrial septal defect by treating an existing atrial septal defect as a treatment option for patients with Cyanotic Congenital heart defects.

According to HealthWise:

An atrial septal defect is an opening in the wall that separates the upper chambers of the heart. It is one of the most common congenital heart defects, which are structural problems that develop before a baby is born or at birth. When an atrial septal defect is present, some oxygen-rich blood that should have been pumped to the body flows from one side of the heart to the other. This blood is then pumped to the lungs. This creates extra work for one side of the heart.

If an atrial septal defect is large, heart failure may occur, although this is not common in children. Many children have no symptoms. So this defect may not be found until a child is older or becomes an adult. A heart catheterization can typically be used to close the opening. This prevents blood from flowing between chambers.

Cyanotic heart defects are defects that allow oxygen-rich blood and oxygen-poor blood to mix. In cyanotic heart defects, less oxygen-rich blood reaches the tissues of the body. This results in the development of a bluish tint (cyanosis) to the skin, lips, and nail beds.

The FDA announced this Class 1 recall, stating that device quality issues have emerged from the clinical use of the Rashkind Balloon Septostomy Catheters. This quality issue can lead to the device breaking, separating or failing during use.  If this occurs, use of the affected product may cause serious adverse health consequences such as damage to blood vessels (vascular injury) and death. According to the FDA, there were two injuries reported from this problem and one death. The recall impacts 142 devices.

3.2.20

By Mike Smith

Last month, Medtronic began a Class 1 recall of 822 units of its Pipeline Flex Embolization Device due to  risk of device fracture, which can lead to serious patient injury or death, according to the FDA Recall Notification.

According to the FDA, the product (“Pipeline Flex”) is a permanent mesh cylinder (stent) braided from platinum and tungsten and cobalt-chromium-nickel alloy wires intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform). The Pipeline Flex also includes a guidewire-based delivery system used to place the implant inside the patient.

The mesh stent does not seem to be the problem, but rather the delivery system that carries the stent to the aneurysm and implants it within the arterial wall, according to the FDA:

Medtronic is recalling their Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the delivery system could fracture while placing the stent inside the patient.

Fractured pieces of the delivery system could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the patient’s condition worse. This can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death.

If a Pipeline Flex Embolization Device (the permanent flow diverting stent) has already been implanted successfully, there is no increased risk to patients due to this issue.

The FDA received 50 Medical Device Reports, with 10 injuries and 1 death, from November 1, 2019 to March 1, 2020.