AngioSculpt® PTCA Scoring Balloon Catheter 2001-3515Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M3702001351515), received between Apr 7, 2020 and Apr 7, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Deflation 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.

• InjuryApr 7, 2020Deflation Problem; Deflation Problem

  THE PATIENT HAD 95% STENOSIS IN THE OSTIAL/PROXIMAL RIGHT CORONARY ARTERY (RCA). A CORDIS JR4 GUIDE CATHETER WAS POSITIONED AND INSERTED A 0.014" BOSTON SCIENTIFIC SAMURAI GUIDE WIRE. THE LESION WAS PRE-DILATED WITH A 3.0 MM NC BALLOON, FOLLOWED BY A 3.5 MM NC BALLOON, BUT THE OPENING OF THE OSTIAL ARTERY WAS NOT GOOD. THE PHYSICIAN DECIDED TO USE AN ANGIOSCULPT DEVICE THAT WAS ADVANCED TO THE LESION WITH NO RESISTANCE. THE BALLOON WAS INFLATED TO 14 ATM, WITH FULL EXPANSION UP TO 15 ATM WITH NO ISSUES. HOWEVER, DURING RETRACTION THE BALLOON COULD NOT BE DEFLATED AND CAUSED A 25 MM LONG PROXIMAL DISSECTION IN THE RCA AND THE PATIENT EXPERIENCED INFERIOR ST ELEVATION, DECREASED RESPIRATORY RATE AND BRADYCARDIA. THE BALLOON WAS DEFLATED AGAIN, AND WITH SOME RESISTANCE IT WAS POSSIBLE TO PULL BACK TO THE AORTA. AT THIS POINT, THE GUIDE WIRE POSITION WAS ABANDONED, AND THE ANGIOSCULPT WAS PULLED BACK TO THE RADIAL ARTERY WITH THE BALLOON STUCK AT THE DISTAL MARKER OF THE GUIDE CATHETER. THE FULL SYSTEM WAS REMOVED AS A UNIT. TO TREAT THE DISSECTION, A NEW JR4 GUIDE CATHETER AND A NEW SAMURAI GUIDE WIRE WAS POSITIONED. THE LESION WAS PRE-DILATED WITH A 3.0 NC BALLOON. THEN A BOSTON SCIE

  Patient problems: Decreased Respiratory Rate; ST Segment Elevation; Vascular Dissection

  MAUDE report 9933329 ↗