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

Model Number	670-308
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire break.
Event or Problem Description
It was reported that a sensor wire was used during surgical procedure.During procedure, it was found that the straight tip sensor wire black flexible tip broke off.The procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire break.Block h11: the device was not returned for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without a proper evaluation of the device or objective evidence, it remains unknown the most probable causes that could have contributed to the event.The review of device history record (dhr) was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of core wire break and unretrieved device fragments (udf) was defined in the risk documentation and is documented accordingly.A labeling review was performed using windchill.The ifu contains detailed device information and instructions for the device use.It was confirmed that the following adverse events are anticipated in the ifu: discomfort/pain, hematuria and infection (including sepsis with symptoms of fever and hypotension).Also, there is no evidence the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling this event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, this complaint is assigned an investigation conclusion code of cause not established the investigation findings do not clearly confirm the presence or absence of the reported problem with the device.
Event or Problem Description
It was reported that a sensor wire was used during surgical procedure.During procedure, it was found that the straight tip sensor wire black flexible tip broke off.The procedure was completed.There were no patient complications as a result of this event.

• 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: 24857428
• Report Number: 2124215-2026-19725
• Device Sequence Number: 15794603
• Product Code: EZB
• UDI-Device Identifier: 08714729302681
• UDI-Public: (01)08714729302681(17)281123(10)38033831
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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: 670-308
• Device Catalogue Number: 670-308
• Device Lot Number: 0038033831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/25/2026
• Date Device Manufactured: 11/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 80 KG