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

Model Number	M0061456140
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Initial reporter facility name: (b)(6) med ctr.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an ascerta ureteral stent was used during a ureteroscopy with laser lithotripsy and stent placement procedure in the kidney, ureter and bladder, performed on (b)(6) 2020.According to the complainant, during the procedure, inside the patient, when the physician attempted to remove the suture, the suture was broken and it ripped the stent forming a small tear in the coil.Reportedly, a visible hole in the bottom part of the coil was noticed.The procedure was successfully completed with another ascerta ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ASCERTA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9848931
• Report Number: 3005099803-2020-01098
• Device Sequence Number: 16749497
• Product Code: FAD
• UDI-Device Identifier: 08714729802976
• UDI-Public: 08714729802976
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: 11/06/2021
• Device Model Number: M0061456140
• Device Catalogue Number: 145-614
• Device Lot Number: 0024728470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1