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

Model Number	M0066703050
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reported event of core wire.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that during a ureteroscopic lithotripsy (ursl) procedure using a sensor guidewire, the physician used a 4.5 fr ureteroscope to place a double-j stent.Following successful stent placement, the hydrophilic coating of the guidewire detached during withdrawal, causing a small segment of the wire to fracture and remain inside the patient.The physician subsequently identified and retrieved the fractured fragment from the patient.The procedure was completed with another of the same device and there were no known patient complications.
Event or Problem Description
It was reported that during a ureteroscopic lithotripsy (ursl) procedure using a sensor guidewire, the physician used a 4.5 fr ureteroscope to place a double-j stent.Following successful stent placement, the hydrophilic coating of the guidewire was peeled off during withdrawal, causing a small segment of the wire to fracture and remain inside the patient.The physician subsequently identified and retrieved the fractured fragment from the patient using froceps.The procedure was completed with another of the same device and there were no known patient complications.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reported event of core wire.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Block h11: product analysis the returned sensor wire was analyzed, and during the inspection, it was found the polytetrafluoroethylene (ptfe) peeled, which confirm the reported event of ptfe peeled; however, for the reported event of core wire break was not possible identify on the returned device.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.Based on the analysis, it is likely that excess force applied during wire removal, or the use of a metal needle/cannula, contributed to the ptfe peeling observed.Based on the analysis results, an investigation conclusion code of adverse event related to procedure was assigned for observed ptfe peeled.

• 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: 23513558
• Report Number: 2124215-2025-81146
• Device Sequence Number: 21258972
• Product Code: EZB
• UDI-Device Identifier: 08714729376354
• UDI-Public: (01)08714729376354(17)280403(10)36231893
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/02/2025

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: M0066703050
• Device Catalogue Number: M0066703050
• Device Lot Number: 0036231893
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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