SYNCHRO2-14 SOFT STRAIGHT 200CM

Description of Event or Problem

THE GUIDEWIRE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT GUIDEWIRE WAS KINKED/BENT AND BROKEN/FRACTURED DURING USE. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED AND CONTINUED WITH OTHER DEVICES. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE GUIDEWIRE WAS SEEN TO BE KINKED/BENT. THE GUIDEWIRE WAS SEEN TO BE BROKEN/FRACTURED 181CM FROM THE PROXIMAL END. A FUNCTIONAL TEST COULD NOT BE CARRIED OUT DUE TO THE DAMAGE. THE REPORTED EVENT OF 'GUIDEWIRE DISTAL TIP POOR SHAPE RETENTION' AND 'GUIDEWIRE FRICTION' COULD NOT BE REPLICATED DURING DEVICE ANALYSIS; HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATION WHEN RETURNED BASED ON THE ANALYSED ANOMALIES. 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. IT WAS REPORTED THAT THE WIRE WAS NOT TAKING THE SHAPE OF THE ARTERY AND WAS SHOWING RESISTANCE. DEVICE ANALYSIS FOUND THAT THE GUIDEWIRE WAS KINKED/BENT AND ALSO BROKEN/FRACTURED APPROXIMATELY 181 CM FROM THE PROXIMAL END. DIMENSIONAL INSPECTION PASSED FOR THE GUIDEWIRE OUTER DIAMETER (OD), WHILE THE DISTAL TIP OD COULD NOT BE ASSESSED AS IT WAS NOT RETURNED. THE REPORTED EVENT COULD NOT BE REPLICATED, BUT THE FINDINGS WERE CONSISTENT WITH THE REPORTED COMPLAINT. AS PER THE ADDITIONAL INFORMATION, THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS. BASED ON ALL AVAILABLE INFORMATION AND THE DEVICE ANALYSIS, IT IS PROBABLE THAT SOME UNKNOWN ANATOMICAL AND/OR PROCEDURAL FACTORS PRESENT DURING THE CLINICAL PROCEDURE MAY HAVE CAUSED THE GUIDEWIRE TO FRACTURE. DIFFICULTY ADVANCING THE COILS WAS ALSO REPORTED. ADVANCING THE GUIDEWIRE AGAINST RESISTANCE CAN CAUSE THE GUIDEWIRE TO LOSE ITS INTENDED SHAPE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED AND ANALYSED EVENT OF 'GUIDEWIRE DISTAL TIP POOR SHAPE RETENTION', 'GUIDEWIRE FRICTION', AND ANALYSED EVENT OF 'GUIDEWIRE BROKEN/FRACTURED DURING USE' 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. AN ASSIGNABLE CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THE ANALYZED EVENT OF 'GUIDEWIRE KINKED/BENT', AS THE ISSUE IS DUE TO HANDLING OF THE PRODUCT OR PORTION OF THE PRODUCT DURING THE CLINICAL PROCEDURE, UPON REMOVAL OF THE PRODUCT FROM THE PACKAGING, OR PREPARATION OF THE PRODUCT PRIOR TO USE.