Scoreflex NC Scoring PTCA Catheter 630-204-1URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955936425), received between May 14, 2024 and May 20, 2024 — classified as 2 injuries.

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.

• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRIMARILY WIRE WITH A NON-CSI/ABBOTT GUIDE WIRE. THERE WAS DIFFICULTY EXPERIENCING WITH THE INITIAL WIRING. THE GUIDE WIRE WAS EXCHANGED FOR A MICROCATHETER. THE VIPERWIRE ADVANCE GUIDE WIRE WAS ADVANCED TO THE RCA WITHOUT ISSUE. MULTIPLE LOW SPEED TREATMENTS WERE PERFORMED. THE OAD WAS REMOVED AFTER SUCCESSFUL TREATMENTS. THE VIPERWIRE WAS EXCHANGED FOR A NON-CSI/ABBOTT GUIDE WIRE. POST DILATION WAS PERFORMED USING A SCOREFLEX BALLOON AND A NON-CSI/ABBOTT BALLOON. TWO DRUG-ELUTING STENTS WERE PLACED. AFTER THE PROCEDURE, REVIEW OF ANGIOGRAPHIC IMAGING REVEALED A SMALL PERFORATION OF THE TREATED VESSEL. INTRAVASCULAR ULTRASOUND (IVUS) DID NOT DETECT A PERFORATION DURING THE PROCEDURE. NO FURTHER MEDICAL INTERVENTION WAS NEEDED, AS THE PERFORATION WAS RESOLVED DURING THE PROCEDURE. THE PATIENT WAS HOSPITALIZED IN STABLE CONDITION. IN THE PHYSICIAN'S OPINION, THE PERFORATION WAS POSSIBLY RELATED TO THE OAD, ALTHOUGH THEY SUSPECTED THE NON-CSI/ABBOTT DEVICES ALSO MAY HAVE CONTRIBUTED.

  Patient problems: Perforation of Vessels

  MAUDE report 19351655 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRIMARILY WIRE WITH A NON-CSI/ABBOTT GUIDE WIRE. THERE WAS DIFFICULTY EXPERIENCING WITH THE INITIAL WIRING. THE GUIDE WIRE WAS EXCHANGED FOR A MICROCATHETER. THE VIPERWIRE ADVANCE GUIDE WIRE WAS ADVANCED TO THE RCA WITHOUT ISSUE. MULTIPLE LOW SPEED TREATMENTS WERE PERFORMED. THE OAD WAS REMOVED AFTER SUCCESSFUL TREATMENTS. THE VIPERWIRE WAS EXCHANGED FOR A NON-CSI/ABBOTT GUIDE WIRE. POST DILATION WAS PERFORMED USING A SCOREFLEX BALLOON AND A NON-CSI/ABBOTT BALLOON. TWO DRUG-ELUTING STENTS WERE PLACED. AFTER THE PROCEDURE, REVIEW OF ANGIOGRAPHIC IMAGING REVEALED A SMALL PERFORATION OF THE TREATED VESSEL. INTRAVASCULAR ULTRASOUND (IVUS) DID NOT DETECT A PERFORATION DURING THE PROCEDURE. NO FURTHER MEDICAL INTERVENTION WAS NEEDED, AS THE PERFORATION WAS RESOLVED DURING THE PROCEDURE. THE PATIENT WAS HOSPITALIZED IN STABLE CONDITION. IN THE PHYSICIAN'S OPINION, THE PERFORATION WAS POSSIBLY RELATED TO THE OAD AND SCOREFLEX BALLOON, ALTHOUGH THEY SUSPECTED THE NON-CSI/ABBOTT DEVICES ALSO MAY HAVE CONTRIBUTED. BACKGROUND: THERE WERE PATI

  Patient problems: Perforation of Vessels

  MAUDE report 19307703 ↗