ZEBRA

Description of Event or Problem

ON (B)(6) 2026, DR. (B)(6) AT (B)(6) MEDICAL CENTER WAS PERFORMING AN ISCHEMIC STROKE INTERVENTION FOR A LEFT ICA TERMINUS OCCLUSION VIA RIGHT RADIAL ARTERY ACCESS. USING A 7F ZEBRA ACCESS SYSTEM (REF# AC7087-095-20-S, LOT# FG251020D-05) AND A ZOOM 71 ASPIRATION CATHETER, THE PHYSICIAN NAVIGATED TO THE TARGET OCCLUSION AND MADE TWO CLOT RETRIEVAL ATTEMPTS. UPON WITHDRAWAL OF THE ZOOM 71 DURING THE SECOND ATTEMPT, THE PHYSICIAN NOTED ABNORMAL RESISTANCE. FLUOROSCOPIC IMAGING REVEALED A SEVERE KINK IN THE ZEBRA CATHETER AT THE AORTIC ARCH, EXTENDING TO THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. THE RESISTIVE FORCES ENCOUNTERED WHILE WITHDRAWING THE ZOOM 71 THROUGH THE KINKED ZEBRA CATHETER ARE CONSISTENT WITH THE REPORTED SEPARATION OF THE ZOOM 71 DISTAL TIP. THE PHYSICIAN INTERVENED BY ADVANCING A RED 62 CATHETER UNDER ASPIRATION TO RETRIEVE THE SEPARATED TIP. FLUOROSCOPIC IMAGING CONFIRMED COMPLETE REMOVAL OF THE TIP WITH NO RESIDUAL FRAGMENTS REMAINING IN THE VASCULATURE. THE ZEBRA CATHETER WAS THEN REMOVED FROM THE PATIENT. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY USING ALTERNATIVE DEVICES. NO ADVERSE PATIENT OUTCOME WAS REPORTED. THE ZEBRA CATHETER WAS RECEIVED BY Q'APEL MEDICAL ON 6/22/2026 AND EVALUATED ON 6/23/2026. PHYSICAL EVALUATION CONFIRMED TWO COMPRESSIVE KINK DEFORMATIONS LOCATED AT APPROXIMATELY 72.5 CM AND 75.5 CM FROM THE PROXIMAL HUB, APPROXIMATELY 3 CM APART, CONSISTENT WITH THE PROCEDURALLY REPORTED KINK LOCATION. LUMEN FLUSH CONFIRMED NO LEAKAGE OR LOSS OF INTEGRITY. MANDREL PASSAGE (0.085") CONFIRMED LUMEN PATENCY THROUGH BOTH KINK SITES, WITH RESISTANCE NOTED AT EACH DEFORMATION. BORESCOPE AND MICROSCOPIC EXAMINATION REVEALED UNIDIRECTIONAL COMPRESSIVE BENDING AT BOTH KINK SITES WITH NO EVIDENCE OF FRACTURE, LINER DELAMINATION, OR MANUFACTURING NONCONFORMANCE. THE DISTAL TIP OF THE ZEBRA CATHETER WAS CONFIRMED INTACT. THE ZOOM 71 CATHETER TIP WAS NOT RETAINED FOR EVALUATION, WHICH IS NOTED AS A LIMITATION OF THE PHYSICAL ANALYSIS. THE FINDINGS OF THE RETURNED PRODUCT EVALUATION ARE CONSISTENT WITH MECHANICAL DEFORMATION RESULTING FROM THE ANATOMICAL AND PROCEDURAL DEMANDS ENCOUNTERED DURING THE INTERVENTION, WITH NO EVIDENCE OF A DEVICE DEFECT OR MANUFACTURING NONCONFORMANCE IDENTIFIED AS A CONTRIBUTING FACTOR.