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

Model Number	M0066703080
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the stent placement procedure, a sensor wire was used.It was found that the coating was observed to be peeled on the proximal handle side portion.The procedure was completed with another of the same device.No patient complications were 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 sleeve detached.Block d4, h4: detailed product information was not provided to bsc.The product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h11: the returned sensor wire was analyzed, and during the inspection, it was observed that the polytetrafluoroethylene (ptfe) peeled at the distal section of the device.Additionally, the sleeve was detached from the wire.Additionally, the sleeve was detached from the wire.A risk review was completed and confirmed that the events of sleeve detached/separated and coating ptfe peeled/sheared were defined in the risk documentation.These event types have been accounted during product risk analysis to support acceptable risk benefits for the product.Based on the information available and the analysis performed, it is possible to conclude that this event could be caused by operational factors.The excess of force applied to remove the wire probably caused the sleeve detachment.Furthermore, the excessive force applied to remove the wire or using a metal needle or cannula probably caused ptfe to peel.Based on the results of the device evaluation, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 25725488
• Report Number: 2124215-2026-36104
• Device Sequence Number: 14859469
• Product Code: EZB
• UDI-Device Identifier: 08714729376361
• UDI-Public: (01)08714729376361
• 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
• Report Date (Section B): 07/06/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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