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

Model Number	670-312
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of device contamination with chemical or other material.
Event or Problem Description
It was reported that prior to a right laser ureteroscopy procedure, the scrub nurse noticed a jelly like clear glob on the distal end of the sensor wire inside the sterile packaging.The guidewire was not used, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that prior to a right laser ureteroscopy procedure, the scrub nurse noticed a jelly like clear glob on the distal end of the sensor wire inside the sterile packaging.The guidewire was not used, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of device contamination with chemical or other material.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.A review of device history record (dhr) indicated that the 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 device foreign material present in device was defined in the risk documentation and is documented accordingly.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.

• 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: 24709074
• Report Number: 2124215-2026-16863
• Device Sequence Number: 10176687
• Product Code: EZB
• UDI-Device Identifier: 08714729257349
• UDI-Public: (01)08714729257349(17)280917(10)37488766
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 670-312
• Device Catalogue Number: 670-312
• Device Lot Number: 0037488766
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 09/18/2025
• 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 Sex: Unknown