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

Model Number	M0066703051
Medical Device Problem Codes	Break (1069); 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	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of sleeve detachment of device or device component.Block h11: upon receipt at our quality assurance laboratory, this sensor wire guidewire underwent a thorough analysis.The device was visually examined and the reported observation could be confirmed.It was observed that the guidewire was unraveled and kinked, the sleeve was detached, and the urethane tip was detached from the wire.It is related to the excess of force applied to the device and technique used, which possibly have affected the performance and integrity of the device.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 adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that the guidewire was stretched and fractured.The patient condition following procedure was stable.
Event or Problem Description
It was reported that the guidewire was stretched and fractured.The procedure was completed with another sensor wire.The patient condition following procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of sleeve detachment of device or device component.Block h11: upon receipt at our quality assurance laboratory, this sensor wire guidewire underwent a thorough analysis.The device was visually examined, and the reported observation could be confirmed.It was observed that the guidewire was unraveled and kinked, the sleeve was detached, and the urethane tip was detached from the wire.It is related to the excess of force applied to the device and technique used, which possibly have affected the performance and integrity of the device.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 adverse event related to procedure was assigned to this investigation.Additional information to field b5: describe event or problem correction to field block h6: device code.

• 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: 22357362
• Report Number: 2124215-2025-42503
• Device Sequence Number: 7937512
• Product Code: EZB
• UDI-Device Identifier: 08714729302650
• UDI-Public: (01)08714729302650(17)270823(10)34703997
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/04/2026

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: M0066703051
• Device Catalogue Number: 670-305
• Device Lot Number: 0034703997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 05/08/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/18/2025; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 52 KG