ZEBRA

Description of Event or Problem

ON JANUARY 23, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A 7F 95 CM SIM 2 ZEBRA CATHETER DURING A MECHANICAL THROMBECTOMY PROCEDURE PERFORMED VIA RIGHT RADIAL ACCESS. THE CATHETER WAS PREPARED AND FLUSHED PER THE INSTRUCTIONS FOR USE AND ADVANCED TO THE HIGH CERVICAL INTERNAL CAROTID ARTERY. TWO THROMBECTOMY PASSES WERE PERFORMED USING ADJUNCTIVE DEVICES. TICI 3 REVASCULARIZATION WAS ACHIEVED. UPON WITHDRAWAL OF THE ZEBRA CATHETER THROUGH THE SHEATH, A PARTIAL SHAFT FRACTURE WAS OBSERVED. NO RESISTANCE OR UNUSUAL MANIPULATION WAS REPORTED DURING USE OR REMOVAL. NO DEVICE FRAGMENTS WERE RETAINED IN THE PATIENT, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS STABLE. RETURNED PRODUCT EVALUATION CONFIRMED A CATHETER SHAFT BREACH APPROXIMATELY 19 CM FROM THE DISTAL TIP, CHARACTERIZED BY POLYMER JACKET AND LINER SEPARATION. MICROSCOPIC AND VISUAL INSPECTION OF THE DAMAGED REGION IDENTIFIED NO ABNORMAL LASER-CUT TUBE (LCT) STRUT PATTERN, PITCH VARIATION, OR GEOMETRIC IRREGULARITY. THE DISTAL TIP SHOWED NO ABNORMALITIES. NO EVIDENCE OF MANUFACTURING NONCONFORMANCE, MATERIAL DEFECT, OR SYSTEMIC DESIGN DEFICIENCY WAS IDENTIFIED.

Additional Manufacturer Narrative

DURING THE PROCEDURE, THE ZEBRA CATHETER WAS INTRODUCED THROUGH A 7F TERUMO SLENDER SHEATH VIA RIGHT RADIAL ACCESS. THE PHYSICIAN INITIALLY ATTEMPTED TO USE A 6F SOFIA CATHETER THROUGH THE ZEBRA; HOWEVER, IT WOULD NOT EXIT AND WAS WITHDRAWN. THE SYSTEM WAS DOWNSIZED TO A 5F SOFIA 125 CATHETER. A MARKSMAN MICROCATHETER AND SOLITAIRE STENT RETRIEVER WERE USED FOR THE FIRST THROMBECTOMY PASS, WHICH WAS UNSUCCESSFUL. THE SYSTEM WAS THEN EXCHANGED FOR A FREECLIMB AND TENZING SYSTEM ADVANCED OVER AN ARISTOTLE 18 GUIDEWIRE, AND A SECOND PASS WAS PERFORMED. NO ASPIRATION WAS PERFORMED THROUGH THE ZEBRA CATHETER.