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

Model Number	M0066703080
Medical Device Problem Codes	Nonstandard Device (1420); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the stent replacement procedure using a sensor wire, the device coating was peeled off.The procedure was completed with another of the same device and there were no known patient complications reported.The analysis of the returned device identified sleeve detachment.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of sleeved detached.Block h11: investigation result: the returned sensor wire was analyzed, and during the inspection, it was identified that the sleeve was detached from the guidewire.There was no evidence of polytetrafluoroethylene (ptfe) peeled on the guidewire, therefore the reported event of "ptfe peeled" was not confirmed.The device history record review confirmed that the device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the investigation, the excess force applied during guidewire removal likely caused detachment of the sleeve.Based on the analysis results, an investigation conclusion code of no problem detected was assigned to the reported event of ptfe peeled.

• 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: 23638982
• Report Number: 2124215-2025-84907
• Device Sequence Number: 9918025
• Product Code: EZB
• UDI-Device Identifier: 08714729376361
• UDI-Public: (01)08714729376361(17)280123(10)35695422
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: 0035695422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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
• Patient Sex: Unknown