MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00556861
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of core wire detached/separated.Block h11: investigation results the returned jagwire was analyzed, and visual and microscopic inspection found that the ptfe coating was peeled.Also, the proximal section of the guidewire was cut off (core wire separated).No other problems with the device were noted.The results of the analysis performed on the returned device found that the core wire was separated.The observed cut is consistent with a mechanical shear event combined with prior bending stress.This indicates that the wire was not cleanly severed but rather compressed and torn, likely due to misaligned tooling, improper cutting equipment, or excessive force applied during separation.These features suggest the cut occurred during handling or use rather than being a manufacturing defect inherent to the material.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was attempted to be used in common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, tip of wire broke off.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition was reported to be fully recovered.This event has been deemed a reportable event based on the investigation finding of core wire detached/separated.Please see block h11 for full investigation details.

• Brand Name: JAGWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24628677
• Report Number: 3005099803-2026-00998
• Device Sequence Number: 8698046
• Product Code: OCY
• UDI-Device Identifier: 08714729268703
• UDI-Public: (01)08714729268703(17)281014(10)37703962
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00556861
• Device Catalogue Number: 5686
• Device Lot Number: 0037703962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown