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

Model Number	M00556581
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire broken.Imdrf impact code f2301 captures the reportable event of additional device required (biopsy grasping forceps).
Event or Problem Description
It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the guidewire experienced an unanticipated distal fracture into several segments, as it was emerging from the tip of the scope and prior to entering the common bile duct.Also, it was noted that the distal tip detached.It was reported that the guidewire was retrieved in two stages.First as an intact unit followed by removal of the fractured segments by biopsy grasping forceps.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22346865
• Report Number: 3005099803-2025-02894
• Device Sequence Number: 8519654
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: (01)08714729339151(17)261110(10)32834957
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 0032834957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/27/2025
• Date Device Manufactured: 11/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown