Scoreflex NC Scoring PTCA Catheter 640-204-1URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955936487), received between Aug 23, 2024 and Sep 3, 2024 — classified as 2 deaths.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathSep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATED AREA WAS AN 85% STENOSED, HEAVILY CALCIFIED DISTAL TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD). FOLLOWING THE PLACEMENT OF AN IMPELLA, THE SCOREFLEX BALLOON WAS ADVANCED WITH THE AID OF A NON-ABBOTT GUIDING CATHETER. THE SCOREFLEX BALLOON WAS INFLATED TWICE TO NOMINAL PRESSURE. ANGIOGRAPHIC IMAGING WAS TAKEN, AND A PERFORATION WAS OBSERVED. THE EXACT LOCATION OF THE PERFORATION IN THE LAD COULD NOT BE DETERMINED. THE PATIENT CODED, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, INTUBATION AND MEDICATION WERE ADMINISTERED. THE PATIENT STABILIZED, AND THREE COVERED STENTS WERE PLACED TO TREAT THE PERFORATION. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR FURTHER OBSERVATION. IT WAS THE PHYSICIAN'S OPINION THE PATIENT'S HEAVY CALCIFICATION CAUSED THE PERFORATION; THE CALCIUM CAUSED INJURY TO THE PATIENT WHEN THE SCOREFLEX BALLOON WAS INFLATED. ADDITIONAL INFORMATION RECEIVED ON 8/20/2024, THE PATIENT EXPIRED ON (B)(6) 2024. IN THE OPINION OF THE PHYSICIAN, ALTHOUGH THE PERFORATION WAS THE CAUSE OF DEATH, THE PATIENT HAD HIGHLY CALCIFIED LESIONS. THE RUPTURE WOULD HAVE BEEN CAUSED BY ANYTHING USED TO BREAK THAT CALCIUM. THERE WAS NO ALLEGATION OF DEFIC

  Patient problems: Cardiac Arrest; Perforation of Vessels

  MAUDE report 20130364 ↗
• DeathAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 2024/8/28 REGARDING THIS CASE (CRF#(B)(4)) AS FOLLOWS, 1.THE PATIENT EXPIRED ON (B)(6) 2024. 2. IN THE OPINION OF THE PHYSICIAN, PERFORATION IS THE PRIMARY AND SECONDARY CAUSE OF DEATH. 3. IN THE OPINION OF THE PHYSICIAN, THE ORBUSNEICH DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. 4. WHY DOES THE PHYSICIAN BELIEVE THE ORBUSNEICH DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH? PER PHYSICIAN "THE PATIENT HAD HIGHLY CALCIFIED LESIONS. THE RUPTURE COULD HAVE BEEN CAUSED BY ANYTHING USED TO BREAK THAT CALCIUM." SO, WE SUBMIT A FOLLOWUP REPORT TO COMPLETE THIS CASE.

  Patient problems: Perforation of Vessels

  MAUDE report 20045313 ↗