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

Model Number	M0066703051
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.Imdrf impact code f1909 captures the reportable event of surgical procedure delayed.
Event or Problem Description
It was reported that during a percutaneous nephrolithotomy procedure, the physician attempted to create a tract from the skin into the patient's kidney using a chiba tip needle and a sensor guide wire.The physician attempted twice but was unable to access the kidney.On the third attempt, under fluoroscopy, a black line was observed within the patient's abdominal region.The physician was uncertain of its exact location at that time.The sensor guidewire was withdrawn, and upon inspection, the physician noted that the hydrophilic tip was partially missing.A different non-boston scientific hydrophilic guide wire was then used; however, due to procedural difficulty, access to the kidney could not be achieved and the procedure was not completed.The physician planned to reoperate on the patient at a later date to remove the retained portion of the guide wire tip.The intervention plan for retrieval was performed, and the detached tip was successfully retrieved from the patient.No further 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: 23717112
• Report Number: 2124215-2025-88798
• Device Sequence Number: 10275201
• Product Code: EZB
• UDI-Device Identifier: 08714729302650
• UDI-Public: (01)08714729302650(17)280327(10)36177821
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: M0066703051
• Device Catalogue Number: 670-305
• Device Lot Number: 0036177821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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: 32 YR
• Patient Sex: Female