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

Model Number	M0066703080
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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 investigation results of sleeve detached.Block h11: the returned sensor wire was analyzed, and during the inspection, it was noted that the polytetrafluoroethylene (ptfe) had peeled at the distal section of the device.Furthermore, the sleeve had detached from the wire, which did not confirm the reported event since the tip showed no damage.Based on the investigation, it can be concluded that observed issues were probably caused by operational factors such as excessive force applied to remove the wire likely led to the sleeve detachment and ptfe peeled.Based on the analysis results regarding the observed detached sleeve, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure, the tip part got separated when it was inserted into the endoscope.The procedure was completed with another of the same device and there were no known patient complications.The analysis of the returned device identified sleeve detachment.
Event or Problem Description
It was reported that during the transurethral lithotripsy procedure, the tip part got separated when it was inserted into the endoscope.The procedure was completed with another of the same device and there were no known patient complications.The analysis of the returned device identified sleeve detachment.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of sleeve detached.Block h11: the returned sensor wire was analyzed, and during the inspection, it was noted that the polytetrafluoroethylene (ptfe) had peeled at the distal section of the device.Furthermore, the sleeve had detached from the wire, which did not confirm the reported event since the tip showed no damage.Based on the investigation, it can be concluded that observed issues were probably caused by operational factors such as excessive force applied to remove the wire likely led to the sleeve detachment and ptfe peeled.Based on the analysis results regarding the observed detached sleeve, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.Correction to field b5 (describe event or problem).

• 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: 23375622
• Report Number: 2124215-2025-75924
• Device Sequence Number: 8870134
• Product Code: EZB
• UDI-Device Identifier: 08714729376361
• UDI-Public: (01)08714729376361(17)270927(10)34946621
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2026

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: M0066703080
• Device Catalogue Number: M0066703080
• Device Lot Number: 0034946621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 05/08/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/15/2025; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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