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

Model Number	M00556581
Medical Device Problem Codes	Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter's address is (b)(6) reported here as the initial reporter address exceeded the character limit for the designated field.Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.
Event or Problem Description
Note: this report pertains to one of four jagwires used in the same patient and procedure.It was reported to boston scientific corporation that a jagwire was attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, while advancing the guidewire into the common bile duct, peeling occurred on the black part of the hydrophilic tip.The same problem occurred with the other three jagwires.Due to this problem, the procedure had to be terminated.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter's address is (b)(6); reported here as the initial reporter address exceeded the character limit for the designated field.Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.Block h11: investigation results the returned jagwire was analyzed, and a visual and microscopic inspection found that the tip was peeled and had sections detached (degradation), also was kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of tip peeled was confirmed.The results of the analysis performed on the returned device found that the tip was peeled and also had sections detached.This problem noted could have been caused due to environment conditions.Product storage conditions of temperature and relative humidity are the main contributors for the jagwire tip material degradation over time.Boston scientific corporation initiated a corrective and preventive action (capa) investigation to determine the root cause of this problem.According to procedure (jagwire tip coating inspection) where it is indicated that the entire pebax (tip) must be inspected for damage, that it does not have holes in the distal tip, and that it has no rough edges, and that if the tip does not meet the required configuration, reject the unit.These steps of the process would have detected the observed damage on the distal tip.The investigation findings and all information available concludes the most probable root cause is cause traced to environment.An investigation to address this problem has been completed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of cancelled/rescheduled - post sedation/sedation unknown was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.
Event or Problem Description
Note: this report pertains to one of four jagwires used in the same patient and procedure.It was reported to boston scientific corporation that a jagwire was attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, while advancing the guidewire into the common bile duct, peeling occurred on the black part of the hydrophilic tip.The same problem occurred with the other three jagwires.Due to this problem, the procedure had to be terminated.There were no patient complications reported as a result of this event.

• 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: 24049627
• Report Number: 3005099803-2026-00170
• Device Sequence Number: 9348709
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: (01)08714729339151(17)260228(10)31143414
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2026

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 Expiration Date: 02/28/2026
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 0031143414
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• Patient Sex: Unknown