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

Model Number	M0066703051
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.
Event or Problem Description
It was reported that, a sensor wire was used in a ureteroscopy procedure.During the procedure, it was noticed that the sleeve was detached.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.Block h11: the returned sensor wire was analyzed, and during the inspection, it was found that the sleeve had become detached and the guidewire was peeled at the distal section, which confirms the reported event.Furthermore, the ptfe was also found to be peeled.Based on the investigation, the excessive force applied during the removal of the wire or the use of a metal needle or cannula likely caused the peeling of the ptfe.Additionally, the sleeve was detached from the wire.The excessive force applied during the removal of the wire probably led to the detachment of the sleeve.Based on the results of the analysis, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.Correction to field g2: report source (other).
Event or Problem Description
It was reported that a sensor wire was used in a ureteroscopy procedure.During the procedure, it was noticed that the sleeve was detached.The procedure was completed with another of the same device and there were no patient complications 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: 23343060
• Report Number: 2124215-2025-74806
• Device Sequence Number: 9470239
• Product Code: EZB
• UDI-Device Identifier: 08714729302650
• UDI-Public: (01)08714729302650(17)280625(10)36846763
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 0036846763
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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 Sex: Unknown