Many Florida residents suffer from heart problems, and as a result, they may require a pacemaker. Pacemakers have leads, which are special wires that attach to the heart muscle and deliver energy. Sometimes one or more of these leads may need to be removed due to a fracture, scar tissue, infection or vein blockage.
When the lead needs to be removed, tears can occur, causing hemorrhaging. Tears are rare, but when they do happen, the Spectranetics Bridge Occlusion Balloon Catheter can help. This device blocks the superior vena cava and reduces blood loss until surgeons can repair the tear.
The Spectranetics Bridge Occlusion Balloon Catheter, however, is being recalled due to a blocked guidewire lumen. The guidewire lumen passes the catheter over a guidewire. Should this guidewire lumen become blocked, it would not be able to control the hemorrhaging and would lead to serious medical issues and possibly even death.
The Food and Drug Administration (FDA) has classified the Bridge Occlusion Balloon Catheter recall as a Class I recall, the most serious of its kind. 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, FMN17H29A
More than 1,900 devices were recalled in the United States. The lots were manufactured between February 13, 2017 and July 18, 2017 and distributed between February 24, 2017 and July 31, 2017.
Spectranetics first sent a notice to affected customers on August 7, 2017 through an “Urgent Medical Device Recall.” Physicians were instructed to check the guidewire lumen and ensure is it open and unblocked before use. They should also have backup units on hand just in case.
Two weeks later, on August 21, 2017, Spectranetics sent another notice informing physicians that all Bridge Occlusion Balloon Catheter devices were affected by this defect and that no permanent solution has been implemented yet. They were given the following instructions:
- Bring extra Bridge Occlusion Balloon Catheter devices into the procedure so that backup devices are readily available.
- Place a guidewire through the venous access site and across the length of the superior vena cava before starting the procedure.
- Ensure a patent lumen by removing the device from the package and placing the catheter over the guidewire. Check the guidewire lumen to see if it is obstructed. If so, discard the device and keeping checking until you find a working device. Return any defective devices to Spectranetics.
- When performing lead extraction procedures, always follow appropriate prevention and management protocols for preparing the patient and having backup devices on hand.
- Complete and return the “Acknowledgement and Receipt Form” to Spectranetics.
Get Legal Help for Your Medical Device Case
Medical devices are created using the latest technology, but sometimes they do not work as planned. They can cause serious complications and even death in some cases. It’s important to hold the manufacturer liable in these cases.
If you have been injured by a defective medical device, the Miami personal injury attorneys at the law offices of Dolan Dobrinsky Rosenblum, LLP can help. We can assess your case and determine your rights to compensation. Request a free consultation by calling our law offices today at 305-371-2692.