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

Model Number	M0066703081
Medical Device Problem Codes	Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
T was reported that a patient underwent a right ureteral metal stent placement.The guidewire was used to guide the catheter placement.During the procedure, it was found that the coating of the guidewire peeled off.The use was stopped, causing no impact on the patient.The procedure was completed with the original device and no patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a24 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 coating was peeled off in different sections and the sleeve did not return, showing evidence of sleeve detachment.It is related to the handling and manipulation of the device during procedure, also an excess of force applied to the device such as operational factors during their use could have cause these issues.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.

• 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: 22687749
• Report Number: 2124215-2025-50286
• Device Sequence Number: 15820920
• Product Code: EZB
• UDI-Device Identifier: 08714729302681
• UDI-Public: (01)08714729302681(17)280108(10)35582499
• 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,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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: M0066703081
• Device Catalogue Number: 670-308
• Device Lot Number: 0035582499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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 Age: 60 YR
• Patient Sex: Female