GATEWAY MR 2.0MM X 9MM - JP

Additional Manufacturer Narrative

BASED ON THE RESULTS OF THE DHR (DEVICE HISTORY RECORD) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. DURING VISUAL INSPECTION, THE DISTAL TIP OF THE SUBJECT BALLOON CATHETER WAS DETACHED SEPARATED. THE SUBJECT BALLOON CATHETER WAS KINKED. A FUNCTIONAL INSPECTION WAS NOT PERFORMED DUE TO DAMAGE. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED FRICTION COULD NOT BE REPLICATED DURING ANALYSIS, HOWEVER THE DAMAGE TO THE DEVICE IS CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION. IT WAS REPORTED THAT THE SUBJECT CATHETER COULD NOT BE RAISED ALONG OVER A NON-STRYKER GUIDING DEVICE DUE TO RESISTANCE THE PATIENTS ANATOMY WAS OF AVERAGE TORTUOSITY. THE DEVICE WAS RETURNED AND THERE WAS KINKING NOTED TO THE SUBJECT BALLOON CATHETER SHAFT AND THE DISTAL END OF THE SUBJECT BALLOON CATHETER HAD BEEN FRACTURED. IT IS PROBABLE THAT THERE WERE PROCEDURAL AND/OR PROCEDURAL COMPLICATIONS PRESENT DURING THE CLINICAL PROCEDURE THAT CAUSED THE SUBJECT BALLOON CATHETER TO BECOME KINKED AND FRACTURED CAUSING THE REPORTED FRICTION DURING ADVANCEMENT OVER THE GUIDEWIRE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED 'BALLOON OR BALLOON CATHETER FRICTION' AND TO THE ANALYZED 'BALLOON CATHETER BROKEN/FRACTURED DURING USE' AND 'BALLOON CATHETER KINKED/BENT', AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

Description of Event or Problem

THE SUBJECT BALLOON WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE DISTAL TIP OF THE SUBJECT BALLOON CATHETER WAS DETACHED SEPARATED DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.