Small Peripheral Cutting Balloon® M001PCBM4015140F0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729819714), received between Jul 16, 2020 and Jul 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 16, 2020Break; Break

  IT WAS REPORTED THAT THE DISTAL PORTION OF THE CATHETER SEPARATED. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT WHEN THE OUTER/PROTECTIVE SHEATH WAS REMOVED, THE DISTAL PORTION OF THE CATHETER BECAME SEPARATED. THE DEVICE WAS NEVER IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10282725 ↗