LEMAITRE VALVULOTOME

Additional Manufacturer Narrative

THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED AT THE SITE; THEREFORE, THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PREVIOUS INVESTIGATIONS INTO THIS ISSUE HAVE FOUND THE FAILURE WAS LIKELY DUE TO A CENTERING HOOP TO WIRE WELDING ERROR ALONG WITH OPERATOR ADJUSTMENT ERROR. DURING THE WELDING PROCESS, THIS CENTERING HOOP WAS LIKELY NOT PROPERLY ALIGNED AGAINST ITS RETAINER SLOT. CAPA 2022-025 WAS PREVIOUSLY IMPLEMENTED TO ADDRESS THIS ISSUE. THE DEVICE INVOLVED WAS MANUFACTURED AFTER THE CAPA WAS IMPLEMENTED. ALTHOUGH THE ISSUE OCCURRED POST-IMPLEMENTATION, THE OVERALL OCCURRENCE OF THIS ISSUE HAS DECREASED SINCE THE CAPA WAS PUT IN PLACE. THE PRODUCTION AND TRACEABILITY RECORD FOR THE DEVICE WAS REVIEWED; NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ALL QUALITY CONTROL TESTS WERE COMPLETED SUCCESSFULLY AND MET SPECIFICATION. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT.

Description of Event or Problem

IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE SHEATH DID NOT FULLY RETRACT, LEAVING THE BLADE EXPOSED. THE DEVICE WAS NOT USED ON A PATIENT. NO PATIENT INJURY WAS REPORTED.