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

Model Number	M0066703081
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a flexible ureteroscopic lithotripsy procedure, a sensor wire was found to be fractured in the middle upon unpacking.The procedure was completed with another of the same device, and no patient complications were noted.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire.Block h11: the returned sensor wire was analyzed, and during the inspection,the ptfe coating was found to be peeled, and the core wire was detached, confirming the reported event.Furthermore, the excess of force applied for the wire removal or the use with a metal needle or cannula probably caused the ptfe peeled.Additionally, core wire was detached.The excess of force applied to remove the wire probably caused the detachment of the core wire.Based on the analysis results, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that, a sensor wire will be used in a flexible ureteroscopic lithotripsy procedure.Upon unpacking, it was found that the guide wire was fractured in the middle.The procedure was completed with another of the same device, and no patient complications were noted.

• 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: 23503661
• Report Number: 2124215-2025-81099
• Device Sequence Number: 9048538
• Product Code: EZB
• UDI-Device Identifier: 08714729302681
• UDI-Public: (01)08714729302681(17)280109(10)35596065
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/08/2026

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: M0066703081
• Device Catalogue Number: 670-308
• Device Lot Number: 0035596065
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 76 KG