Percuflex Locking Loop M0064101110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729005223), received between Nov 14, 2022 and Nov 14, 2022 — classified as 1 injury.

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. 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.

• InjuryNov 14, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUTANEOUS LOCKING LOOP NEPHROSTOMY CATHETER WAS PLACED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCN) PROCEDURE PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, IT WAS NOTICED THAT THE CATHETER WAS LEAKING DUE TO THE BROKEN CATHETER. A TAPE WAS TEMPORARILY WRAPPED AROUND THE CATHETER TO PREVENT THE LEAKAGE. FINALLY, THE CATHETER WAS REMOVED, AND WAS REPLACED WITH A NEW CATHETER ON (B)(6) 2022. NOTE: THE PHOTOS SUBMITTED BY THE CUSTOMER SHOWS THE CATHETER WAS BROKEN IN TWO SEPARATE PIECES AND A KINKED ON THE PROXIMAL END OF THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787649 ↗