AXS VECTA 046 CATH 146CM - US

Additional Manufacturer Narrative

BASED ON THE RESULTS OF THE DEVICE HISTORY RECORD (DHR) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. VISUAL INSPECTION WAS PERFORMED AS THE SHAFT OF THE SUBJECT CATHETER WAS KINKED. THE CATHETER SHAFT WAS SEEN TO BE BROKEN/FRACTURED 32 CM FROM THE HUB. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED SUBJECT DEVICE. THE REPORTED 'CATHETER SHAFT KINKED/BENT' WAS CONFIRMED. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. 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. DURING ANALYSIS, THE SHAFT OF THE SUBJECT CATHETER WAS SEEN TO BE KINKED/BENT. THE CATHETER SHAFT WAS SEEN TO BE BROKEN/FRACTURED 32 CM FORM THE HUB. BASED ON THE AVAILABLE INFORMATION AND CONDITION OF RETURNED CONDITION, IT IS PROBABLE THAT THE ROTATING HEMOSTATIC VALVE (RHV) WAS NOT ADEQUATELY LOOSENED DURING THE RETRIEVAL ATTEMPT, WHICH MAY HAVE INCREASED FRICTIONAL RESISTANCE ON THE CATHETER SHAFT. FURTHERMORE, IT IS ALSO PROBABLE THAT THE TORTUOUS ANATOMY, MIGHT HAVE FURTHER INCREASED THE RESISTANCE ENCOUNTERED DURING USE, MAKING THE DEVICE MORE SUSCEPTIBLE TO INTERNAL DAMAGE UNDER TENSION. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED 'CATHETER SHAFT KINKED/BENT' AS WELL AS ANALYZED ' CATHETER SHAFT BROKEN/FRACTURED DURING USE¿ AS THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS DURING USE.

Description of Event or Problem

THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SHAFT OF THE SUBJECT DEVICE WAS BROKEN/FRACTURED DURING USE. THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.