Hydra Jagwire M00556070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729747123), received between May 21, 2019 and Dec 30, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 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 HYDRA JAGWIRE WAS USED IN THE ESOPHAGUS DURING A ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, THE HYDRA JAGWIRE PASSED THROUGH THE STENOSIS AND HANARO ESOPHAGEAL STENT WAS PLACED. AN EXAMINATION WAS PERFORMED IMMEDIATELY AFTER THE PROCEDURE AND CONFIRMED THE CONTRAST AGENT HAD LEAKED INTO THE PERITONEUM. IT WAS NOTED THERE WAS A PERFORATION IN THE STOMACH AND AN EMERGENCY OPERATION WAS PERFORMED. IN THE PHYSICIAN'S ASSESSMENT THE GUIDEWIRE CONTRIBUTED TO THE PERFORATION HOWEVER THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE.

  Patient problems: Perforation

  MAUDE report 13119192 ↗
• MalfunctionOct 30, 2020Difficult to Advance; Appropriate Device Problem Term/Code Not Available; Difficult to Advance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA JAGWIRE GUIDEWIRE WAS USED IN THE APPLICABLE DURING A DUODENAL STENT PLACEMENT PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE WOULD NOT ADVANCE SMOOTHLY THROUGH THE DELIVERY SYSTEM. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10765863 ↗
• InjuryMay 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE GUIDEWIRE WAS USED IN THE TRANSVERSE COLON DURING A LOWER GASTROINTESTINAL TRACT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A SCOPE WAS INSERTED AND REACHED THE TARGET LOCATION. ANGIOGRAPHY WAS PERFORMED THROUGH THE SCOPE; HOWEVER, THE OPENING COULD NOT BE SEEN DUE TO STENOSIS. AFTER THAT, THEY TRIED TO CANNULATE THE STENOSIS USING THE HYDRA JAGWIRE GUIDEWIRE. THE PHYSICIAN ADVANCED FURTHER THE GUIDEWIRE AS HE THOUGHT THAT THE GUIDEWIRE WAS ABLE TO PENETRATE THE STENOSIS. A TANDEM ANGIOGRAPHIC CATHETER WAS THEN INSERTED ALONG WITH THE GUIDEWIRE WHEREIN ANGIOGRAPHY WAS PERFORMED IN THE OPENING SIDE OF THE STENOSIS. THE PHYSICIAN, ALTHOUGH IT WAS NOT CERTAIN, HE BELIEVED THAT IT WAS ALREADY AT THE LUMEN OF THE COLON AND THEN THE TANDEM WAS REMOVED. A HANAROSTENT WAS THEN INSERTED ALONG WITH THE GUIDEWIRE, THEN IT WAS POSITIONED, AND THE STENT WAS DEPLOYED. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY WAS PERFORMED AND SHOWED THAT THE COLON STENT WAS DEPLOYED IN THE ABDOMINAL CAVITY. ACCORDING TO THE PH

  Patient problems: Internal Organ Perforation

  MAUDE report 8628530 ↗