Q Distal Access Catheter Q6-69145Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B293Q6691450), received between Jun 27, 2019 and Aug 18, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Off-Label Use; Material Separation; Detachment of Device or Device Component; Off-Label Use; Material Separation; Detachment of Device or Device Component

  A 75-YEAR-OLD MALE PATIENT PRESENTED WITH A LEFT SUPERIOR DIVISION M2 OCCLUSION. PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN LEFT M2 WHERE THE Q6 CATHETER WAS USED WITH NEURON MAX LONG SHEATH, PROWLER MICROCATHETER, SYNCHRO GUIDEWIRE, SOLITAIRE STENT RETRIEVER AND PENUMBRA ENGINE. NEURON MAX PLACED IN LEFT ICA. LARGE CERVICAL CAROTID ARTERY ANEURYSM THAT WAS IN THE MID TO DISTAL CERVICAL CAROTID ARTERY & NEURON MAX PLACED IN THAT ANEURYSM. WHEN ADVANCED THE Q6 CATHETER TO THE MCA OCCLUSION, IT WAS OVER A PROWLER MICROCATHETER & SYNCHRO GUIDEWIRE. ONCE MICROCATHETER PASSED THE CLOT, PHYSICIAN DEPLOYED SOLITAIRE SR, AND WHILE HE LET IT DWELL INSIDE THE CLOT, HE NOTICED THAT THE CATHETER STARTED TO FLOW UP THE MCA. CATHETER HAD BECOME DETACHED FROM THE PUSHER WIRE. HE TRIED TO PULL THE STENT RETRIEVER AND CAPTURE THE CATHETER, BUT HE WAS UNABLE TO - STENT RETRIEVER WENT THROUGH DETACHED CATHETER. TRIED A SNARED BALLOON TO CAPTURE THE CATHETER BUT WAS UNSUCCESSFUL. STOPPED PROCEDURE & CALLED VASCULAR SURGERY, WHO REMOVED THE CATHETER FROM THE ICA SURGICALLY. PATIENT'S DEFICITS REMAINED STABLE, NO NEUROLOGICAL WORSENING FROM THE INITIAL CLINICAL PRESENTATION. NO VESSEL INJURY NOTED, A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577075 ↗
• MalfunctionMay 15, 2023Mechanical Problem; Mechanical Problem

  DURING A STROKE THROMBECTOMY PROCEDURE, THE PHYSICIAN ADVANCED THE Q6 CATHETER TO M1 CLOT WITH A 3MAX AND ASPIRATED THE CLOT. THE CLOT WAS RETRIEVED, AND THE PATIENT WAS READY FOR AN ANGIOGRAM. PHYSICIAN NOTICED THE MARKER BAND AFTER PERFORMING THE ANGIOGRAM. AFTER SEVERAL ATTEMPTS TO RETRIEVE THE MARKER BAND IN THE SHEATH IT ESCAPED AND LODGED BACK IN THE M1. THE PATIENT HAD TICI 3 AND THE PHYSICIAN OPTED TO LEAVE THE MARKER BAND AS ACUTELY IT WAS NOT AFFECTING FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930548 ↗
• InjuryJun 27, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STROKE PROCEDURE THE Q CATHETER WAS USED BUT COMPLETE REVASCULARIZATION WAS NOT ACHIEVED. THE Q CATHETER WAS REINTRODUCED INTO THE VASCULATURE, UPON RETRACTION RESISTANCE WAS FELT. THE CATHETER WAS FORCIBLE RETRACTED AND SEPARATED INTO TWO PIECES WITH ONE PIECE REMAINING IN THE PATIENTS BODY. ATTEMPTS MADE TO SNARE THE PIECE WERE UNSUCCESSFUL. DETACHED SEGMENT WAS SUCCESSFULLY RETRIEVED DURING CAROTID ENDARTERECTOMY.

  Patient problems: Infarction, Cerebral

  MAUDE report 8740940 ↗