MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ASCERTA? FIRM; STENT, URETERAL

Model Number	M0061456470
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the reported lot number could not be matched to the reported device upn.Therefore, the lot expiration and device manufacture dates are unknown at this time.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a150207 captures the reportable event of stent difficult to remove.Patient code.Patient code e2008 captures the reportable event of unretrieved device fragment.Impact code f1901 captures the reportable event of additional surgery required.Impact code f1001 captures the reportable event of cancelled/rescheduled procedure.
Event or Problem Description
It was reported that an ascerta firm ureteral stent was implanted into the kidney of the patient.Following the procedure, a ureteroscopy for stent removal procedure was performed, and it was noticed that the renal coil would not unwind, resulting to the device being partially explanted and a portion of the stent remains implanted.Another ureteroscopy procedure was scheduled to remove the unretrieved fragment.There were no patient complications reported as a result of this event.This event is also being reported for cancelled/rescheduled procedure with a patient under anesthesia or sedation status unknown.

• Brand Name: ASCERTA? FIRM
• Common Device Name: STENT, URETERAL
• 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: 22980704
• Report Number: 2124215-2025-62257
• Device Sequence Number: 15840241
• Product Code: FGE
• UDI-Device Identifier: 08714729861782
• UDI-Public: (01)08714729861782
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• 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
• Report Date (Section B): 09/05/2025

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: M0061456470
• Device Catalogue Number: M0061456470
• 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: 08/14/2025
• Initial Report FDA Received Date: 09/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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