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

Model Number	M0066703080
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to 02/01/2026 as no event date was reported.Block h6: imdrf device code a0401 captures the reportable investigation results of core wire break.Block h11: the returned sensor wire was analyzed, and during the inspection, it was found that the guidewire was detached and unraveled at the distal section, which did not confirm the reported event ptfe peeled.Based on the available information, it is likely that excessive force applied during device removal caused to the detachment and unraveling of the guidewire.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and confirmed that the event of "ptfe peeled, guidewire unraveled and core wire detached/separated" were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on the results of the device evaluation, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during a transurethral laser lithotripsy procedure, a sensor wire was used.While the guidewire was inside the patient, the ptfe coating was observed to have peeled off.The analysis of the returned device identified core wire break.

• 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: 24749910
• Report Number: 2124215-2026-17777
• Device Sequence Number: 18426383
• Product Code: EZB
• UDI-Device Identifier: 08714729376361
• UDI-Public: (01)08714729376361(17)280909(10)37420513
• 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
• Report Date (Section B): 03/31/2026

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: M0066703080
• Device Catalogue Number: M0066703080
• Device Lot Number: 0037420513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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