Description of Event or Problem · 0
DURING A NEUROVASCULAR PROCEDURE ON (B)(6) 2026, PERFORMED VIA FEMORAL ACCESS USING A 7FR SHEATH, A ZEBRA 7FR 105 CM SIM2 CATHETER WAS USED IN CONJUNCTION WITH A WINGSPAN SYSTEM. THE CATHETER WAS INSPECTED PRIOR TO USE, AND NO DEFECTS WERE OBSERVED. THE CATHETER WAS ADVANCED TO A HIGH CERVICAL POSITION; HOWEVER, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING A MICROCATHETER AND MICROWIRE TO THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, A KINK WAS OBSERVED FLUOROSCOPICALLY IN THE AORTIC ARCH REGION. A SECOND KINK WAS SUBSEQUENTLY VISUALLY IDENTIFIED IN A SEGMENT OF THE CATHETER EXTERNAL TO THE PATIENT. SALINE LEAKAGE WAS OBSERVED AT THE LOCATION OF THE EXTERNAL KINK. THE CATHETER WAS FLUSHED FOLLOWING REMOVAL FROM THE PATIENT, CONFIRMING A LUMEN BREACH/FRACTURE CORRESPONDING TO THIS REGION. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ZEBRA CATHETER FROM THE SAME LOT, WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED. RETURNED PRODUCT EVALUATION CONFIRMED A LOCALIZED LUMEN BREACH/FRACTURE ASSOCIATED WITH THE EXTERNALLY KINKED REGION. MICROSCOPIC EVALUATION OF THE FRACTURE REGION DID NOT IDENTIFY EVIDENCE OF MANUFACTURING OR DESIGN-RELATED NONCONFORMANCE. THE OBSERVED DAMAGE PATTERN WAS CONSISTENT WITH MECHANICAL OVERSTRESS AND TORSIONAL DEFORMATION DURING CLINICAL USE. A CATHETER LUMEN FRACTURE REPRESENTS A DEVICE MALFUNCTION THAT, IF IT WERE TO RECUR, COULD LEAD TO AN INABILITY TO DELIVER THERAPY OR REQUIRE DEVICE EXCHANGE DURING A PROCEDURE. VISUAL INSPECTION FURTHER IDENTIFIED NUMEROUS ADDITIONAL AREAS OF FLATTENING AND KINKING THROUGHOUT THE CATHETER SHAFT. THE FLATTENING PATTERN WAS PRESENT ON OPPOSING SIDES OF THE SHAFT AND WAS CONSIDERED POTENTIALLY CONSISTENT WITH EXTERNAL COMPRESSION. THE EXTENT AND DISTRIBUTION OF THIS ADDITIONAL DAMAGE ARE NOT CONSISTENT WITH THE REPORTED IN-PROCEDURE MALFUNCTION AND WERE NOT VISIBLY IDENTIFIABLE IN THE CUSTOMER-PROVIDED IMAGE OBTAINED POST-REMOVAL; THEREFORE, THESE FINDINGS ARE CONSIDERED MORE LIKELY ATTRIBUTABLE TO POST-PROCEDURE HANDLING AND/OR RETURN PACKAGING.