Zebra M0066701110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729752776), received between May 25, 2021 and May 25, 2021 — classified as 1 injury.

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.

• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZEBRA GUIDEWIRE WAS USED IN THE URETER DURING A HOLMIUM LASER LITHOTRIPSY AND DOUBLE J STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2021.DURING THE PROCEDURE, IN THE PHYSICIAN'S ASSESSMENT THE TIP OF THE GUIDEWIRE MAY HAVE CAUSED A PERFORATION IN THE PATIENT'S URETER. HOWEVER, IT WAS REPORTED THERE WAS NO MALFUNCTION WITH THE ZEBRA GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE.POST PROCEDURE, ON (B)(6), 2021, THE PATIENT EXPERIENCED ABDOMINAL PAIN. A COMPUTERIZED TOMOGRAPHY EXAMINATION REVEALED URINARY EXOSMOSIS. IT WAS REPORTED THAT THIS CAUSED THE BOSTON SCIENTIFIC DOUBLE J STENT TO SHIFT IN POSITION. THE DOUBLE J TUBE STENT WAS REMOVED AND REPLACED WITH A NEW ONE.ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2021:THE STENT DEVICE WAS PLACED AFTER HOLMIUM LASER LITHOTRIPSY. IN ADDITION, THE ZEBRA GUIDEWIRE WAS NOT USED AT THE SAME TIME AS THE HOLMIUM LASER. URINARY EXOSMOSIS REFERS TO EXTRAVASATION OF URINE. PERFORATION WITH THE ZEBRA WIRE WAS NOT OBSERVED UNDER FLUOROSCOPY DURING THE PROCEDURE.

  Patient problems: Abdominal Pain; Extravasation; Perforation

  MAUDE report 11880761 ↗