Scoreflex NC Scoring PTCA Catheter 640-104-1URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06934955936463), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 injury.

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.

• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS THE TARGET TREATMENT AREA. FOLLOWING SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) AND STENT PLACEMENT A TREK NC BALLOON WAS ADVANCED FOR POST DILATION THEN THE SCOREFLEX BALLOON WAS ADVANCED, WITH THE AID OF A NON-CSI OR ABBOTT GUIDE WIRE, AND INFLATED TO 12 ATMOSPHERE PRESSURE (ATM) AND REMOVED. OPTICAL COHERENCE TOMOGRAPHY (OCT) AND ANGIOGRAPHY WAS CHECKED AND A PERFORATION WAS OBSERVED. ANGIOPLASTY WAS PERFORMED USING NEW TREK BALLOON TO TREAT THE PERFORATION BUT WAS UNSUCCESSFUL. ECMO AND IMPELLA WERE PERFORMED AND A NEW NON-CSI OR ABBOTT GUIDE WIRE WAS ADVANCED AND A STENT WAS PLACED TO TREAT THE PERFORATION. THE PATIENT WAS STABLE AND TRANSFERRED TO A DIFFERENT FACILITY FOR BYPASS SURGERY. THE PHYSICIAN'S OPINION WAS THE PATIENT'S HEAVILY CALCIFIED ARTERY WAS A FRACTURE AS TO WHY THE PERFORATION OCCURRED BUT COULD NOT SAY WHICH ONE DEVICE CAUSED OR CONTRIBUTED TO THE PERFORATION. IT WAS NOTED THAT THE VESSEL WAS NOT PREPPED PROPERLY BY USING AN OVERSIZED STENT.

  Patient problems: Perforation of Vessels

  MAUDE report 18865543 ↗