Percuflex™ Plus M0061752740Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729041214), received between Sep 26, 2019 and Sep 26, 2019 — 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 16, 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 26, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING CLOSURE OF THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THERE WAS DIFFICULTY RETRACTING THE GUIDEWIRE AND WHEN THE STENT WAS PULLED BACK, STENT BUCKLED/ACCORDION WAS OBSERVED. THE PHYSICIAN USED A LASER FIBER INSIDE THE BLADDER TO CUT THE GUIDEWIRE AND WAS ABLE TO REMOVE THE STENT OUTSIDE THE PATIENT. A DIFFERENT MODEL OF STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THE STENT SHAFT WAS DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125063 ↗