Description of Event or Problem · 0
DURING A NEUROVASCULAR PROCEDURE PERFORMED ON (B)(6) 2026 VIA RIGHT RADIAL ACCESS, A ZEBRA 7F 95 CM SIM2 CATHETER WAS REPORTEDLY ADVANCED THROUGH TORTUOUS ANATOMY INVOLVING A SHARP INNOMINATE ARTERY TAKEOFF. RESISTANCE WAS REPORTEDLY ENCOUNTERED DURING ADVANCEMENT AND WITHDRAWAL. DURING REMOVAL, A KINK WAS REPORTEDLY OBSERVED ALONG THE DISTAL SHAFT OF THE CATHETER. WHILE WITHDRAWING THE DEVICE, THE CATHETER REPORTEDLY SEPARATED NEAR THE PROXIMAL SHAFT REGION, RESULTING IN SEPARATION INTO TWO PIECES. THE DISTAL CATHETER SEGMENT REPORTEDLY REMAINED PARTIALLY WITHIN THE PATIENT VASCULATURE AND WAS PHYSICIAN INTERVENTION WAS REQUIRED TO REMOVE THE RETAINED CATHETER SEGMENT FROM THE PATIENT VASCULATURE. THE PHYSICIAN REPORTEDLY RE-ACCESSED THE PATIENT AND COMPLETED THE PROCEDURE SUCCESSFULLY USING A DIFFERENT CATHETER. THE PATIENT OUTCOME WAS REPORTED STABLE POST-PROCEDURE. THE RETURNED DEVICE WAS RECEIVED FOR EVALUATION IN TWO SEPARATED PIECES. VISUAL EXAMINATION CONFIRMED CATHETER SEPARATION APPROXIMATELY 2.5 CM DISTAL TO THE STRAIN RELIEF. THE RETURNED CATHETER LENGTH WAS CONSISTENT WITH MANUFACTURED SPECIFICATION AND NO SIGNIFICANT ELONGATION WAS IDENTIFIED. ADDITIONAL SHAFT BENDS/DEFORMATIONS WERE OBSERVED APPROXIMATELY 47 CM AND 72 CM FROM THE PROXIMAL END OF THE DISTAL SEPARATED SEGMENT. DUE TO THE RETURNED PACKAGING CONFIGURATION AND POST-USE HANDLING CONDITION, IT COULD NOT BE CONCLUSIVELY DETERMINED WHETHER THESE DEFORMATIONS ORIGINATED DURING CLINICAL USE OR SUBSEQUENT RETURN HANDLING. THE DAMAGE OBSERVED IS CONSISTENT WITH DEFORMATION ASSOCIATED WITH COILING/BENDING OF THE DEVICE DURING RETURN PACKAGING. MICROSCOPIC EVALUATION OBSERVED CUT PATTERN SPACING CONSISTENT WITH SPECIFICATION WITHOUT EVIDENCE OF STRUCTURAL IRREGULARITIES, MATERIAL DEFECTS, OR OTHER MANUFACTURING NONCONFORMANCE'S ADJACENT TO THE SEPARATION REGION. THE FRACTURE MORPHOLOGY APPEARED IRREGULAR/TORN WITHOUT EVIDENCE OF LOCALIZED INWARD COMPRESSION, CRUSHING, OR ABNORMAL REINFORCEMENT DEFORMATION. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION RESULTS SUPPORT A MECHANICAL LOADING/USE-RELATED FAILURE MECHANISM ASSOCIATED WITH ADVANCEMENT AND WITHDRAWAL THROUGH TORTUOUS ANATOMY WITH PROCEDURAL RESISTANCE.