Description of Event or Problem · 0
ON MARCH 19, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A ZEBRA 7F CATHETER THAT OCCURRED ON (B)(6) 2026 DURING AN ANEURYSM EMBOLIZATION PROCEDURE PERFORMED VIA RADIAL ACCESS USING A 7F SLENDER SHEATH. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED A KINK IN THE PROXIMAL REGION OF THE CATHETER AT THE JUNCTION BETWEEN THE CATHETER SHAFT AND THE STRAIN RELIEF NEAR THE HUB. LEAKAGE WAS NOTED AT THE SITE OF THE KINK, INDICATING A LOSS OF CATHETER WALL INTEGRITY (BREACH). TO MANAGE THE LEAKAGE, THE PHYSICIAN MAINTAINED A SOFIA CATHETER WITHIN THE ZEBRA CATHETER AND APPLIED AN EXTERNAL DRESSING (TEGADERM) TO THE AFFECTED AREA OF THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. AT THE TIME OF THIS REPORT, THE SPECIFIC DEVICE PART NUMBER AND LOT NUMBER HAVE NOT BEEN PROVIDED BY THE USER FACILITY. THE DEVICE REMAINS AT THE USER FACILITY AND HAS NOT YET BEEN RELEASED FOR RETURN EVALUATION. Q'APEL MEDICAL HAS INITIATED FOLLOW-UP EFFORTS TO OBTAIN THE DEVICE AND ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION, INCLUDING DEVICE RETURN AND PRODUCT IDENTIFICATION.