PRUITT IRRIGATION OCCLUSION CATHETER

Additional Manufacturer Narrative

INADEQUATE TRAY SEALS WERE FOUND ON SOME SAMPLES FROM THE IMPACTED PRODUCT LINES. THERE HAVE NOT BEEN ANY COMPLAINTS OR REPORTS OF ADVERSE EVENTS RELATED TO THE ISSUE.

Description of Event or Problem

WE HAVE DETERMINED THAT THERE COULD BE INSUFFICIENT PRODUCT PACKAGING ON A PORTION OF THE TRAY SEALS ACROSS THREE PRODUCT LINES: TUFTEX® OVER-THE-WIRE EMBOLECTOMY CATHETER, PRUITT® OCCLUSION CATHETER, PRUITT® IRRIGATION OCCLUSION CATHETER. THE INADEQUATE TRAY SEAL ISSUE WAS OBSERVED DURING AN UNRELATED TEST TO TUFTEX® OTW CATHETERS. IT WAS THEN FURTHER REVIEWED AND CONFIRMED BY QUALITY AND MANUFACTURING ENGINEERING WHERE SOME PARTS COULD EXHIBIT VOIDS ON THE SEAL AREA IN THE LOCATION WHERE THE TUBING CONNECTS TO THE BOAT TRAY. THE VOIDS WERE OBSERVED VISUALLY AGAINST BACKLIGHT AND CONFIRMED UPON OPENING OF TYVEK LID. SEAL INTEGRITY TESTING (DYE PENETRATION) OF OTHER SAMPLES WITH VISUALLY DETECTED VOIDS SUBSEQUENTLY CONFIRMED FAILURES IN SOME OF THE SAMPLES, INDICATING COMPROMISED PACKAGING, WHICH CAN ALLOW MICROORGANISMS TO ENTER AND CONTAMINATE THE DEVICE, LEADING TO POTENTIAL INFECTION TRANSMITTED BY THE COMPROMISED DEVICE. BASED ON THE ISSUE, A FIELD CORRECTIVE ACTION IS BEING INITIATED BY LEMAITRE TO RECALL THESE DEVICES (CLASS II RECALL). NOTE: THIS IS REPORT 2 OF 3 TO ADDRESS PRUITT IRRIGATION OCCLUSION CATHETERS.