Recall of Bridge Occlusion Balloon Catheter
By: Cohen, Placitella & Roth @ Oct 11, 2017
The medical device manufacturing company Spectranetics Corp. recently announced that it would be recalling its bridge occlusion balloon catheter due to device defects that create patient risks. Here’s what you need to know about this recall.
Catheters Recalled Due to Device Defects
The bridge occlusion balloon catheter is designed specifically to block the superior vena cava (the large vein that receives blood from various parts of the body and delivers it to the heart). The purpose of this intentional blockage is to control against hemorrhage (loss of blood from a ruptured blood vessel) during certain procedures.
According to reports, including the FDA medical device recall alert, the balloon catheters have been recalled by the company because there may be a blocked guidewire lumen in some device units. (A guidewire is a wire that is used to guide the placement of the catheter).
Potential Patient Harm as Result of Defective Device
The FDA report cited above continues to read that if a defective balloon catheter were used, and the guidewire lumen was indeed blocked, the effects could be catastrophic. To be sure, the FDA has classified the recall as a class 1 recall, the most serious type of recall. This classification is based on the fact that the placement of a blocked guidewire lumen would mean an incorrect positioning of the device, which in turn means a patient’s hemorrhage would not be controlled. This could result in the delay of critical life-saving treatment and severe blood loss, which as a result could have tragic adverse effects for an affected patient, including loss of life.
How Spectranetics Is Handling the Recall
Spectranetics sent a notification to affected customers (hospitals and healthcare professionals) informing them of the defect and providing them with a warning of the defect’s potential effects. The notification also told doctors and healthcare professionals that before they use a Spectranetics’ bridge occlusion balloon catheter, they should first ensure that the guidewire lumen is open and unblocked. Should the device but unopened, they should be prepared with non-defective balloon catheters on hand.
Patient Deaths and Injuries
Fortunately, there have been no patient injuries or deaths reported that are linked to the defective balloon catheters, although at least nine reports of blocked guidewire lumens were reported to the company prior to device recall. While the company is in the process of replacing the defective batch (balloon catheters manufactured between February 13, 2017, and July 18, 2017), doctors must also exercise caution. Should a healthcare professional encounter a defective device, it is important that they know how to recognize the defect and act quickly to use another in its place.
What to Do If You Are Affected
If you are a patient who suffers serious harm as a result of a device defect, you have the right to seek damages for your losses. To learn more about patient rights following an injury caused by a defective medical device, contact our Philadelphia medical device litigation lawyers today for a free consultation.