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

Model Number	M0061456120
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned ascerta ureteral stent was analyzed, and a visual evaluation noted that the stent suture hole was torn.The suture string and the positioner were not returned with the device.The reported event was not confirmed.According to the product analysis, the problem found is an issue that could have been generated by the user or due to the interacting of the device with the suture string; it's important to mention that the suture string was not returned and the device was outside the original pouch.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a ascerta ureteral stent was used during a cystoscopy with stent placement procedure in the ureter, performed on (b)(6) 2021.During the procedure and inside the patient, when the physician was placing the stent over the guidewire, the suture string broke.The broken suture and stent was removed by the use of graspers.Another ascera ureteral stent was opened and succesfully completed the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent suture hole torn.

• Brand Name: ASCERTA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12409129
• Report Number: 3005099803-2021-04403
• Device Sequence Number: 11807603
• Product Code: FAD
• UDI-Device Identifier: 08714729802945
• UDI-Public: 08714729802945
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: 02/04/2023
• Device Model Number: M0061456120
• Device Catalogue Number: 145-612
• Device Lot Number: 0026756369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1