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

Model Number	M0066703080
Medical Device Problem Codes	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	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, upon removing the guidewire from the protective hoop, the blue section at the hand end was found to have detached.The procedure was completed with another of the same device and there were no known patient complications reported.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of sleeve detachment of device or device component.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of sleeve detachment of device or device component.The returned sensor wire was analyzed, and during the inspection, it was noted that the ptfe was peeled at the distal section of the device, and the sleeve was detached from the wire.The investigation into the peeling of the ptfe, is evidence that excessive force applied during the removal of the wire or the use of a metal needle or cannula likely caused the ptfe to peel.Furthermore, concerning the detachment of the sleeve from the wire, it is probable that excessive force applied during the removal of the wire led to the sleeve becoming detached.Based on the analysis results, 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, upon removing the guidewire from the protective hoop, the blue section at the hand end was found to have detached.The procedure was completed with another of the same device and there were no known 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: 23173347
• Report Number: 2124215-2025-68006
• Device Sequence Number: 18363522
• Product Code: EZB
• UDI-Device Identifier: 08714729376361
• UDI-Public: (01)08714729376361(17)271219(10)35525366
• 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
• Report Date (Section B): 11/10/2025

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: M0066703080
• Device Catalogue Number: M0066703080
• Device Lot Number: 0035525366
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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