HydroFrame 10 Advanced 101036HFRM-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777023612), received between Aug 20, 2020 and Aug 20, 2020 — classified as 1 injury.

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

• InjuryAug 20, 2020Difficult to Remove; Stretched; Detachment of Device or Device Component; Difficult to Remove; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT COIL EMBOLIZATION WAS PERFORMED AS TREATMENT FOR A RIGHT INTERNAL CAROTID PCOM ARTERY ANEURYSM. AN ATTEMPT WAS MADE TO REPOSITION THE COIL AND DURING RETRACTION, THE COIL STRETCHED AND THEN UNEXPECTEDLY DETACHED. THE DISTAL END OF THE IMPLANT COIL REMAINED IN THE ANEURYSM AND APPROXIMATELY 90% OF THE IMPLANT COIL WAS OUTSIDE THE ANEURYSM. ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED COIL WITH A SNARE DEVICE, BUT THEY WERE UNSUCCESSFUL. THE IMPLANT COIL WAS STRETCHED AND THINNED IN ITS PROXIMAL SEGMENT AS A RESULT OF THE COIL RETRIEVAL ATTEMPTS. THE STRETCHED SEGMENT OF COIL OUTSIDE THE ANEURYSM WAS PRESSED AGAINST THE WALL OF THE INTERNAL AND PRIMITIVE STRAIGHT CAROTID ARTERIES, THE BRACHIOCEPHALIC TRUNK, AND THE AORTA DOWN TO THE COMMON FEMORAL ARTERY. THE PATIENT WAS PLACED ON HEPARIN POST-OPERATIVELY. THERE WAS NO REPORTED PATIENT INJURY AND THERE WERE NO CLINICAL COMPLICATIONS FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10429336 ↗