Q Distal Access Catheter Q3-36163Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B293Q3361630), received between Nov 9, 2022 and Nov 9, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2022Use of Device Problem; Use of Device Problem

  PATIENT ARRIVED WITH A CTA SHOWING A LEFT M2 OCCLUSION. IV THROMBOLYTIC WAS ADMINISTERED. ANGIOGRAM DEMONSTRATED THE CLOT MIGRATED TO M3. NEURON MAX, PHENOM 27, ARISTOLE 18 AND Q CATHETER WAS USED FOR ASPIRATION. A Q4 CATHETER WAS USED FIRST. THE Q4 CATHETER APPEARED TO BE OVERSIZED. AS THE MICROSYSTEM WAS REMOVED, THE Q4 PROLAPSED TO MAIN BRANCH AND LURCHED FORWARD. ASPIRATION WAS PERFORMED IN THE MAIN TRUNK. THE Q4 CATHETER WAS REPLACED WITH Q3 CATHETER. DUE TO PATIENT MOVEMENT A NEW DSA WAS REQUIRED. AN ANGIOGRAM WAS PERFORMED THROUGH THE Q3 CATHETER. THE ANGIOGRAM PUSHED CONTRAST INTO THE INFARCTED AREA. PATIENT HAD A HEMORRHAGIC CONVERSION DUE TO FORCEFUL INJECTION. THE CONVERSION REQUIRING HEMICRANIECTOMY AFTER THE PROCEDURE. PATIENT SHOWED FUNCTIONAL RECOVERY.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15759928 ↗