Small Peripheral Cutting Balloon® M001PCBO2015140F0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729819721), received between Sep 25, 2019 and Sep 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 25, 2019Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON HAS REMOVAL DIFFICULTY. THE 99% TIGHTLY STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED DISTAL POSTERIOR TIBIAL ARTERY. A 2.00MM /1.5CM/ 140CM SMALL PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, TWO ATTEMPTS WERE MADE TO INFLATE THE BALLOON; HOWEVER THE BALLOON DID NOT INFLATE AND STARTED FILLING THROUGH THE WIRE PORT INSTEAD OF INTO THE BALLOON. REMOVAL DIFFICULTY WAS NOTED WHEN WITHDRAWING THE DEVICE FROM THE PATIENT'S BODY. IT WAS FURTHER REPORTED THAT THE BALLOON WAS SLOWLY WITHDRAWN OVER THE WIRE, AND PULLING THE WIRE BACK. THERE WAS NO INTERVENTION DONE TO REMOVE THE BALLOON FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT WAS GOOD POST PROCEDURE WITH NO ADVERSE OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9117611 ↗