Description of Event or Problem · 1
BOSTON SCIENTIFIC FLEXIMA AND PERCUFLEX DRAINAGE CATHETER FAMILY (PIGTAIL STYLE). BOSTON SCIENTIFIC CORPORATION IS INITIATING AN URGENT FIELD CORRECTION RELATED TO ITS FLEXIMA "AND PERCUFLEX" DRAINAGE CATHETER FAMILY (PIGTAIL STYLE). WE HAVE RECEIVED COMPLAINTS INDICATING THAT, DURING THE ATTEMPTED REMOVAL OF THE DEVICE, SUTURES WERE SEPARATED FROM THE CATHETER AND REMAINED IN THE PATIENT. IN ONE INSTANCE IT WAS REPORTED THAT SURGICAL INTERVENTION WAS UTILIZED TO REMOVE THE SUTURE. THE MOST LIKELY PATIENT RISK/INJURY THAT CAN BE REASONABLY EXPECTED TO OCCUR WITH THIS TYPE OF EVENT WOULD BE THE NEED FOR ADDITIONAL INTERVENTION WHERE THE PHYSICIAN REQUIRES REMOVAL OF THE SUTURE; AND THE MOST SERIOUS INJURY THAT IS REASONABLY EXPECTED TO OCCUR IS IN PATIENTS WITH AN ABCESS OR EMPYEMA, WITH A DELAY IN HEALING WHERE THE SUTURE IS NOT REMOVED. AS A RESULT OF OUR INVESTIGATION INTO THESE COMPLAINTS AND OUR FINDINGS, BOSTON SCIENTIFIC HAS DECIDED TO REVISE THE DIRECTIONS FOR USE (DFU) FOR ALL AFFECTED PRODUCTS TO INCLUDE MORE DETAILED INFORMATION ABOUT THIS ISSUE. UNTIL SUCH TIME AS THE REVISED DFU BECOMES AVAILABLE WITH PURCHASED PRODUCTS, WE ARE PROVIDING THIS IMPORTANT INFORMATION TO OUR CUSTOMERS THROUGH THIS URGENT FIELD CORRECTION NOTIFICATION.