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

Model Number	M00556001
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by the bsc sales representative.The healthcare facility is: (b)(6) hosp (b)(6).Address: (b)(6).Phone: (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of aborted procedure.Block h11: investigation results.The device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, response was not received.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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
Note: this report pertains to a hydratome rx 44, hydra jagwire, and advanix rx biliary stent with naviflex rx delivery system used during the same procedure.It was reported to boston scientific corporation that a hydratome rx 44, hydra jagwire, and advanix rx biliary stent with naviflex rx delivery system was used during a procedure performed on (b)(6) 2026.During the procedure, the customer experienced difficulty deploying two plastic biliary stents over a hydrawire.The guidewire could not be advanced beyond the stent/suture/pusher assembly.The customer retracted the black guide catheter to reposition it prior to advancing it over the wire and attempted deployment multiple times without success.Force was subsequently applied, resulting in suture breakage and stent misdeployment.The procedure was aborted and no stent was placed.There were no patient complications reported as a results of this event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25386453
• Report Number: 3005099803-2026-02291
• Device Sequence Number: 10718577
• Product Code: EZB
• UDI-Device Identifier: 08714729648437
• UDI-Public: (01)08714729648437(17)280220(10)35901422
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/25/2026

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: M00556001
• Device Catalogue Number: M00556001
• Device Lot Number: 0035901422
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 02/20/2025
• 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