Jagwire M00556610Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729747260), received between Sep 21, 2017 and Jun 21, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2023Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED IN THE SIGMOID COLON DURING A COLON STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE GUIDEWIRE WAS PEELED AND DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE CORE WIRE BROKEN. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172173 ↗
• MalfunctionNov 29, 2022Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE GUIDEWIRE TIP SOFT PART OF ABOUT FIVE MM CAME OFF AND REMAINED IN THE BILE DUCT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE COREWIRE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882517 ↗
• MalfunctionOct 19, 2021Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP) PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, PTFE COATING WAS PEELED. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF COREWIRE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661202 ↗
• MalfunctionMay 27, 2021Break; Defective Device; Adverse Event Without Identified Device or Use Problem; Break; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED IN A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING PREPARATION, THE GUIDEWIRE COREWIRE TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JUNE 7, 2021: DURING PREPARATION WHEN THE COATING ON THE TIP WAS ACTIVATED USING SALINE BEFORE INSERTING INTO PATIENT, THE PHYSICIAN NOTICED THE GUIDEWIRE TIP WAS KINKED/BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895197 ↗
• MalfunctionDec 10, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED IN THE COMMON BILE DUCT DURING STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE CANNULA WAS INSERTED INTO THE PATIENT, THE JAGWIRE GUIDEWIRE WAS ADVANCED INTO THE BILE DUCT THROUGH THE CANNULA. THE CANNULA WAS PULLED OUT AND AN ENDOSCOPIC SPHINCTEROTOMY DEVICE WAS THEN ADVANCED OVER THE GUIDEWIRE. HOWEVER, IT WAS NOTICED THAT THE CORE WIRE OF THE GUIDEWIRE WAS BROKEN WHICH FAILED THE OTHER DEVICES TO BE INSERTED. THE STUMP WAS CUT USING SCISSORS, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147384 ↗
• InjurySep 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2017-02798 AND 3005099803-2017-02884 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A JAGWIRE GUIDEWIRE WAS USED TOGETHER WITH A WALLFLEX DUODENAL SOFT UNCOVERED STENT WHICH WAS IMPLANTED TO TREAT A SEVERE STENOSIS DUE TO A DUODENAL TUMOR FROM THE DUODENAL BULB TO THE DESCENDING LIMB OF THE DUODENUM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE GUIDEWIRE (THE SUBJECT OF MFR. REPORT#3005099803-2017-02884) THROUGH THE STENOSIS, WHICH REPORTEDLY TOOK ABOUT 90 MINUTES. AFTER THE STENT (THE SUBJECT OF THIS REPORT) WAS SUCCESSFULLY IMPLANTED, THE PHYSICIAN PERFORMED FLUOROSCOPY TO CHECK THE STENT'S PLACEMENT. IT WAS NOTED THAT THE CONTRAST MEDIA NEAR THE HORIZONTAL LIMB OF THE DUODENUM WAS NOT CLEAR AROUND THE DUODENUM AND THE PHYSICIAN SUSPECTED THAT THERE WAS A PERFORATION. A COMPUTED TOMOGRAPHY (CT) SCAN

  Patient problems: Perforation

  MAUDE report 6883872 ↗