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

Model Number	M0066703090
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a transurethral lithotripsy procedure, a sensor wire was used, fraying was observed along the length of the guidewire, and a tear was noted in the middle section.It was observed that it got caught immediately after the guidewire was started to use.The guidewire was removed, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of event of core wire break.Block h11: the returned sensor wire was analyzed, and during the inspection, it was found that the guidewire unraveled due to core wire detached and ptfe peeled, which confirmed the reported event.The excess force applied during the attempted removal of the guidewire, or the use of a metal needle or cannula, likely caused the ptfe coating to peel.In addition, the guidewire became unraveled due to detachment of the core wire.The excessive force used to remove the wire also likely contributed to the detachment of the urethane tip, as well as the observed unraveling and kinking of the guidewire.Based on the analysis findings, the investigation was assigned the conclusion code: adverse event related to procedure.
Event or Problem Description
It was reported that, during a transurethral lithotripsy procedure, a sensor wire was used, fraying was observed along the length of the guidewire, and a tear was noted in the middle section.It was observed that it got caught immediately after the guidewire was started to use.The guidewire was removed, and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SENSOR
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23995891
• Report Number: 2124215-2026-01085
• Device Sequence Number: 18772586
• Product Code: EZB
• UDI-Device Identifier: 08714729376378
• UDI-Public: (01)08714729376378(17)280413(10)36300969
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/02/2026

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: M0066703090
• Device Catalogue Number: M0066703090
• Device Lot Number: 0036300969
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/01/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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