The Bridge device is used to temporarily block the superior vena cava for emergency control of hemorrhage. Spectranetics said the August 25 recall was prompted by nine reports of blocked guidewire lumens, although no deaths or serious injuries were reported.
“Based on inspection, the frequency of a potentially blocked guidewire lumen is estimated to be approximately 10%,” the company said. “As the Bridge occlusion balloon serves an important role in preventing blood loss in the event that a patient requires emergent surgery as a result of an SVC tear during a lead extraction, Spectranetics does not want to remove product from the field until replacements can be provided.
“Spectranetics believes it is in the best interest of the patient to continue to have access to the Bridge device. Orders of Bridge devices, subject to potential guidewire blockage, will continue to be placed (inventory permitting).Once we can confirm that a solution is available, your existing inventory will be swapped out,” the company said.
Spectranetics said blocked lumens can be identified by attempting to fully pass the guidewire through the lumen before the procedure; if blocked, the company advised users to swap the device out for another. The issue is believed to be linked to a third-party supplier, the company said.
Earlier this month Philips closed its $2.2 billion deal to acquire Spectranetics, consolidating it into its image-guided therapy business.