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

Model Number	M0066703090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e4: this event was reported to the fda via a voluntary medwatch report.The report number is (b)(4).Block h6: imdrf device code a0401 captures the reportable event of core wire break.
Event or Problem Description
It was reported that during a cystoscopy with right laser lithotripsy and suction aspiration of stone, right retrograde pyelogram, and right ureteral stent placement, a sensor wire was used.The surgeon observed that the sensor wire had broken off in the kidney.The broken wire was successfully retrieved without damage to surrounding anatomical structures.The procedure was completed without further incident.No harm occurred to the patient, and the patient recovered as expected and was discharged home.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire break.Block h11: correction to field block h10 related report number (1) block h11: the device was not returned for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without proper evaluation of the device or objective evidence, it remains unknown the most probable causes that could have contributed to the event.A review of the device history record indicated that the device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of "core wire break" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, this complaint is assigned an investigation conclusion code of "unable to exclude device problem' the investigation findings do not clearly confirm the presence or absence of the reported problem with the device.
Event or Problem Description
It was reported that during a cystoscopy with right laser lithotripsy and suction aspiration of stone, right retrograde pyelogram, and right ureteral stent placement, a sensor wire was used.The surgeon observed that the sensor wire had broken off in the kidney.The broken wire was successfully retrieved without damage to surrounding anatomical structures.The procedure was completed without further incident.No harm occurred to the patient, and the patient recovered as expected and was discharged home.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire break.Block h11: correction to field block h10 related report number (1).
Event or Problem Description
It was reported that during a cystoscopy with right laser lithotripsy and suction aspiration of stone, right retrograde pyelogram, and right ureteral stent placement, a sensor wire was used.The surgeon observed that the sensor wire had broken off in the kidney.The broken wire was successfully retrieved without damage to surrounding anatomical structures.The procedure was completed without further incident.No harm occurred to the patient, and the patient recovered as expected and was discharged home.

• 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: 24472342
• Report Number: 2124215-2026-11111
• Device Sequence Number: 9615899
• Product Code: EZB
• UDI-Device Identifier: 08714729376378
• UDI-Public: (01)08714729376378(17)280319(10)36116522
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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: 0036116522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 03/13/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/11/2026; 04/07/2026
• Date Device Manufactured: 03/20/2025
• 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 Age: 46 YR
• Patient Sex: Unknown