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

Model Number	M0066703081
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf a0401 captures the reportable event of core wire break.Imdrf e2008 captures the reportable event of unretrieved device fragments.Imdrf f23 captures the reportable event of unexpected medical intervention.Imdrf f2301 captures the reportable event of additional device required.Mdrf f1901 captures the reportable event of additional surgery.
Event or Problem Description
It was reported that the patient underwent cystoscopy, right retrograde pyelogram, ureteroscopic holmium laser lithotripsy, stone basketing, and tight ureteral stent placement.During stone clearance and fluoroscopic evaluation of stone clearance progress, the working sensor wire was not visualized.A separate wire fragment was seen on fluoroscopy in the upper pole.The wire fragment was visualized and attempts were made to retrieve it using a zero tip basket and piranha forceps.However, retrieval of the broken wire fragment was unsuccessful.The patient was returned to the operating room.A flexible ureteroscope was advanced into the kidney.Pyeloscopy was performed.The retained sensor wire fragment was identified and successfully grasped with a three-prong basket and removed.No patient complications were 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: 22152028
• Report Number: 2124215-2025-34746
• Device Sequence Number: 7639153
• Product Code: EZB
• UDI-Device Identifier: 08714729302681
• UDI-Public: (01)08714729302681(17)271113(10)35275335
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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: 0035275335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/05/2025
• Date Device Manufactured: 11/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White