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

Model Number	M0066703051
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detachment of device or device component.
Event or Problem Description
It was reported that during procedure, the wires are different.Additionally, it was noted that the sleeve was detached.The procedure was completed using an alternate device and there were no patient complications reported.
Event or Problem Description
It was reported that during procedure, the wires are different.Additionally, it was noted that the sleeve was detached.The procedure was completed using an alternate device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of sleeve detachment of device or device component.Block h11: the sensor wire did not return for analysis, but media analysis was performed and it was observed that a comparison between two different wires, but the damage to the detached sleeve was not visible.With all the available information, boston scientific concludes that the reported event of sleeve detached was not confirmed.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.All necessary inspection was performed to ensure the integrity of the device for its used.Based on the information available and investigation results, a conclusion code of cause not established 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: 21632324
• Report Number: 2124215-2025-16126
• Device Sequence Number: 7424781
• Product Code: EZB
• UDI-Device Identifier: 08714729302650
• UDI-Public: (01)08714729302650(17)270912(10)34839572
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 0034839572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/07/2025
• Date Device Manufactured: 09/12/2024
• 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