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

Model Number	M0066703051
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a ureteroscopy procedure, the patient's ureter was perforated, attributed to the sensor wire.The physician noted this was not the first occurrence with the same lot number.He described the wire as darker blue, shinier, thinner, and more slippery than normal, with no rigidity or visible lines on the video tower.In his opinion, the outer coating was missing, which contributed to the perforation and patient complications.The procedure was completed with a sensor wire from a different lot number obtained from stony brook main hospital, which appeared normal in appearance and feel.No further patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f12 captures the reportable event of serious injury/illness/impairment.
Event or Problem Description
It was reported that during a ureteroscopy procedure, the patient's ureter was perforated, attributed to the sensor wire.The physician noted this happened with another of the same lot number.The physician felt different, the wire was darker blue, shinier, thinner, and more slippery than normal, with no rigidity or visible lines on the video tower, which contributed to the perforation and patient complications.The procedure was completed with a sensor wire from a different lot number obtained from stony brook main hospital, which appeared normal in appearance and feel.No further patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f12 captures the reportable event of serious injury/illness/impairment.Block h11: updated field b5: event description correction block e1: initial reporter phone.

• 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: 23790543
• Report Number: 2124215-2025-90623
• Device Sequence Number: 13381137
• Product Code: EZB
• UDI-Device Identifier: 08714729302650
• UDI-Public: (01)08714729302650(17)280922(10)37526716
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: M0066703051
• Device Catalogue Number: 670-305
• Device Lot Number: 0037526716
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 09/23/2025
• 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: Other
• Patient Sex: Unknown