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

Model Number	M00557001
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagwire revolution was attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, upon trying to remove the guidewire from the tome, resistance was felt and upon pulling the wire, it broke.It was reported that the core wire broke into two separate pieces.The procedure was completed with a different guidewire.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire break.
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the reportable event of core wire break.H11: investigation results: the returned jagwire revolution was analyzed, and a visual and microscopic inspection found that the tip was peeled and kinked.However, the core wire was not broken.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of core wire break was not confirmed.The results of the analysis performed on the returned device found that the core wire was not broken.The tip was peeled and kinked and those damages were likely to have occurred during the device manipulation.It is also possible that, in the procedure, an excess of force was applied to the device.For example, during the guidewire insertion or removal of the device through another device or the interaction with the scope or tools that could lead to the observed damages.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire revolution was attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, upon trying to remove the guidewire from the tome, resistance was felt and upon pulling the wire, it broke.It was reported that the core wire broke into two separate pieces.The procedure was completed with a different guidewire.There were no patient complications reported as a result of this event.

• Brand Name: JAGWIRE REVOLUTION
• 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: 22646877
• Report Number: 3005099803-2025-03647
• Device Sequence Number: 21025077
• Product Code: OCY
• UDI-Device Identifier: 08714729934974
• UDI-Public: (01)08714729934974(17)280404(10)36237571
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/08/2025

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: M00557001
• Device Catalogue Number: 56480
• Device Lot Number: 0036237571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2025
• 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: Male