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

Model Number	M00556040
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of core wire broken.
Event or Problem Description
It was reported to boston scientific corporation that a hydra jagwire was used in the stomach and duodenum during a pancreatography and pancreatogastrostomy procedure to treat cancer performed on (b)(6) 2025.During the procedure, it was observed that the coating on the guide had come off, and a part of the guide had broken off.It was then reported that the core wire of the device broke.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fully recovered.
Event or Problem Description
It was reported to boston scientific corporation that a hydra jagwire was used in the stomach and duodenum during a pancreatography and pancreatogastrostomy procedure to treat cancer performed on (b)(6) 2025.During the procedure, it was observed that the coating on the guide had come off, and a part of the guide had broken off.It was then reported that the core wire of the device broke.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fully recovered.Additional information received january 20, 2026.It was reported that a snare was used to retrieve the broken core wire.
Additional Manufacturer Narrative
Block h2: (additional information).Block b5, block h6 have been updated based on the additional information received on january 20, 2026.Block h6: imdrf device code a0501 captures the reportable event of core wire broken.Imdrf impact code f2301 captures the reportable event of additional device required (snare) to retrieve the detached piece.Block h11: (investigation result).The returned hydrajagwire was analyzed, and a visual and microscopic evaluation noted that the core wire was broken, and the section where the wire broke was blackened.Additionally, the ptfe coating was peeled.No other problems with the device were noted.The reported event of core wire break was confirmed.Upon analysis, it was found that the core wire was broken, and the section where the wire broke was blackened.Based on the condition of the device, the observed cut is consistent with a mechanical shear event combined with prior bending stress.The presence of tip deformation, material smearing, and heat discoloration indicates that the wire was not cleanly severed but rather compressed and torn.It is most likely due to misaligned tooling, improper cutting equipment, or excessive force applied during separation.These features suggest the cut occurred during handling or use rather than being a manufacturing defect inherent to the material.Additionally, the ptfe coating was peeled.This condition could have been caused due to attempts to advance through a difficult anatomy, insertion or removal of the guidewire through or from another device or the interaction with the scope hitting the device against a hard surface.Based on all gathered information, the most probable root cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 24064112
• Report Number: 3005099803-2026-00194
• Device Sequence Number: 9387535
• Product Code: EZB
• UDI-Device Identifier: 08714729747093
• UDI-Public: (01)08714729747093(17)280610(10)36737199
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: M00556040
• Device Catalogue Number: M00556040
• Device Lot Number: 0036737199
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown