inforMED
MalfunctionDQY

ZEBRA

Received Mar 2, 2026 · Event occurred Jan 30, 2026

Report 3015614-2026-00011 · MDR key 24480527

Device

Generic name

Catheter, Percutaneous

Model number

FG 01764-01

Catalog number

AC7087-095-20-B

Lot number

FG250925D-05

Product problems

  • Break

Patient

NA · Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

DURING A NEUROVASCULAR PROCEDURE PERFORMED BY DR. (B)(6), A ZEBRA WAS USED VIA A 7F SLENDER INTRODUCER SHEATH. AFTER SELECTION OF THE RIGHT INTERNAL CAROTID ARTERY AND REMOVAL OF A 5F SIM2 COOK CATHETER, THE ADJUNCTIVE DEVICES (VECTA 46, V17, AND SYNCHRO) WERE ADVANCED THROUGH THE ZEBRA CATHETER, A FRACTURE WAS OBSERVED AT THE DISTAL SEGMENT. A 0.035" GLIDEWIRE WOULD NOT PASS THROUGH THE FRACTURED REGION. THE ZEBRA CATHETER WAS GENTLY WITHDRAWN FROM THE PATIENT; THE SHAFT REMAINED ATTACHED DURING REMOVAL, BUT COMPLETELY SEPARATED AFTER EXITING THE SHEATH. AT THE TIME OF THIS REPORT, Q'APEL MEDICAL HAS NOT RECEIVED THE DEVICE FOR EVALUATION.