FDA classifies bridge occlusion balloon catheter recall as class I
A recent recall of a bridge occlusion catheter has been classified as class I, the most serious kind, due to the possibility of blocked guidewire lumen in select device units, according to an FDA safety alert.
Model 590-001 of the Bridge Occlusion Balloon Catheter (Spectranetics), which the company recalled on August 7, is designed to temporarily block the superior vena cava in the event of hemorrhage, according to the alert.
If used during a procedure, devices with a blocked guidewire lumen would not be properly positioned, causing inability to control hemorrhagic bleeding, the FDA stated in the alert.
Over 1,900 devices manufactured between Feb. 13 and July 18, 2017, and distributed between Feb. 24 and July 31, 2017, were recalled in the U.S., the agency stated.
According to the alert, the affected lot numbers are FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN17D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A, FMN17H03A, FMN17H03A, FMN17H03A, FMN17H10A and FMN17H29A.
After the initial recall in August, Spectranetics sent a notice directing physicians to confirm that the guidewire lumen is open and unblocked prior to start of the procedure and to have backup units on hand, according to the alert.
Spectranetics sent customers an updated notice on August 21, notifying them that all bridge devices could potential have guidewire blockage. According to the alert, Spectranetics recommended that physicians:
- Place a guidewire through the venous access site and across the length of the superior vena cava before the start of the procedure.
- Consider removing the bridge device from its packaging and placing the catheter over the guidewire prior to the start of the procedure to ensure a patent lumen.
- Discard the device if the guidewire lumen is obstructed and test another until a working device has been identified. Defective devices should be returned to Spectranetics.
- Be aware that all inventory of the product will continue to have the potential for a guidewire lumen blockage until Spectranetics has implemented a permanent solution.
- Bring extra inventory into the procedure so that there is a backup device on hand.
- Always follow appropriate complication prevention and management protocols as they relate to patient preparation and surgical backup for lead extraction procedures.
The FDA stated that Spectranetics recommends health care professionals and patients report any adverse events or side effects related to the use of the product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.