Hydra Jagwire M00556050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729747109), received between Aug 20, 2019 and Aug 20, 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. 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.

• MalfunctionAug 20, 2019Break; Detachment of Device or Device Component; Difficult to Advance; Break; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE GUIDEWIRE WAS USED IN THE HEPATIC PORTAL DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED (B)(6) 2019. ACCORDING TO THE COMPLAINANT, TWO HYDRA JAGWIRES WERE USED IN THE PLACEMENT OF NON BOSTON SCIENTIFIC STENT EACH GUIDEWIRE WAS PLACED ONE LEFT AND RIGHT LOBES BEFOREHAND. THE STENT WAS PLACED FROM THE LEFT HEPATIC DUCT. AFTER PLACEMENT, THE DELIVERY WAS REMOVED WHILE LEAVING THE GUIDEWIRE. DURING THE PROCEDURE, THE LEFT GUIDEWIRE WAS DIFFICULT TO ADVANCE WITHOUT PASSING THROUGH THE CELL OF THE STENT. PEELING OF THE GUIDEWIRE WAS SEEN IN THE ENDOSCOPE. AS THE LEFT GUIDEWIRE WAS REMOVED, THE DISTAL TIP WAS DETACHED AND COREWIRE WAS EXPOSED. REPORTEDLY, THERE WAS NO COMPLAINT AGAINST THE RIGHT GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A NEW HYDRA JAGWIRE GUIDEWIRE. ON AUGUST 6, 2019, PHOTOS WERE RECEIVED REFLECTING THAT THE CORE WIRE WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8913038 ↗