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

Model Number	M0066703090
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a cystoscopy with rt laser lithotripsy and suction aspiration of stone, rt retrograde pyelogram and rt uretal stent, the sensor wire was noted by the surgeon to have broken off in the kidney.The wire was retrieved without damage to the structure.Case continued without further incident, no harm to the patient, patient recovered and 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
• MDR Report Key: 24220489
• Report Number: 24220489
• Device Sequence Number: 18483275
• Product Code: EZB
• UDI-Device Identifier: 08714729376378
• UDI-Public: (01)08714729376378(17)280319(10)36116522
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

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
• Device Model Number: M0066703090
• Device Catalogue Number: M0066703090
• Device Lot Number: 36116522
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/20/2026