MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HYDRA JAGWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M00556040
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hydra jagwire was attempted to be used in the bile duct during an endoscopic ultrasound (eus) rendezvous procedure to treat a bile duct stricture performed on (b)(6) 2025.During the procedure, the coating of the guidewire appeared to have a rough surface, making it difficult to remove and causing the coating to peel/strip from the wire.The wire became stuck in the accompanying fnb eus needle and could not be removed.The needle was forcefully extracted only after the scope was removed from the patient with both the needle and wire still connected.As a result, the procedure was canceled, and the patient was scheduled for ptc (percutaneous transhepatic cholangiography) the next day.Two photos of the device were provided, and one clearly shows the guidewire coating is rough and distorted.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.Block h11: investigation results: the hydra jagwire device was not returned as it was reported to be disposed.A technical analysis could not be performed.However, a media analysis was performed on the photos provided by the complainant where it can be observed that the device has a rough condition.No other problems with the device were noted.According to the media analysis performed, it was possible to observe the guidewire has a rough condition, however, the most probable cause of the reported event cannot be established due to lack of evidence.The product was not returned for analysis as it was reported to be disposed, and a technical analysis could not be performed.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.

• Brand Name: HYDRA JAGWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-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: 22155773
• Report Number: 3005099803-2025-02513
• Device Sequence Number: 12972211
• Product Code: EZB
• UDI-Device Identifier: 08714729747093
• UDI-Public: (01)08714729747093(17)260614(10)31830196
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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 Expiration Date: 06/14/2026
• Device Model Number: M00556040
• Device Catalogue Number: M00556040
• Device Lot Number: 0031830196
• 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: 05/14/2025
• Initial Report FDA Received Date: 06/05/2025
• Date Device Manufactured: 06/15/2023
• 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