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

Model Number	M0066703081
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	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf device code a0501 captures the reportable event of sleeve detachment of device or device component.
Event or Problem Description
It was reported that a sensor wire was used during ureteroscopy procedure.The physician placed a sensor wire into the ureter, left it in place, removed the old ureteral stent.It was noted that a piece of the distal end of the sensor wire has sheared off in the bladder.The piece was 5 inches in length.The physician was able to remove the detached piece from the bladder.The procedure was completed using the original device.There were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf impact code f23 captures the reportable investigation results of unexpected medical intervention.Imdrf device code a0501 captures the reportable investigation results of sleeve detachment of device or device component.Block h11: the sensor wire was not returned for analysis.However the media analysis was performed on the reported pictures of the device and the pouch, and it was observed that the sleeve was detached from the wire.With all the available information, boston scientific concludes that the reported event of sleeve detached was confirmed.This could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could lead to sleeve separation from the sensor wire.Based on the information available, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a sensor wire was used during ureteroscopy procedure.The physician placed a sensor wire into the ureter, left it in place, removed the old ureteral stent.It was noted that a piece of the distal end of the sensor wire has sheared off in the bladder.The piece was 5 inches in length.The physician was able to remove the detached piece from the bladder.The procedure was completed using the original device.There were no patient complications reported.

• 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: 21994985
• Report Number: 2124215-2025-28220
• Device Sequence Number: 4478780
• Product Code: EZB
• UDI-Device Identifier: 08714729302681
• UDI-Public: (01)08714729302681(17)280129(10)35737181
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0066703081
• Device Catalogue Number: 670-308
• Device Lot Number: 0035737181
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/17/2025
• Date Device Manufactured: 01/29/2025
• 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 Sex: Unknown