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

Model Number	M0061456130
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0150207 captures the reportable event of stent difficult to remove.Imdrf device code a0414 captures the reportable event of stent torn material, inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that an ascerta ureteral stent was used during a stent placement procedure in the left kidney performed on (b)(6) 2024.During insertion, when the stent was implanted, the suture was cut and removed, however, the stent was stuck inside the scope.It was noted that the stent was found torn through the hole where the strings were looped.The procedure was successfully completed with non-boston scientific device.There were no patient complications reported as a result of this event.

• Brand Name: ASCERTA
• 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: 18597218
• Report Number: 2124215-2024-02947
• Device Sequence Number: 8117046
• Product Code: FAD
• UDI-Device Identifier: 08714729802969
• UDI-Public: 08714729802969
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/29/2024

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 Expiration Date: 10/12/2025
• Device Model Number: M0061456130
• Device Catalogue Number: 145-613
• Device Lot Number: 0032630233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2023
• 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: Female