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

Model Number	M0061921220
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 a polaris ultra ureteral stent was used during a ureteroscopic lithotripsy procedure in the ureter performed on (b)(6)2021.During the procedure, inside the patient, when the physician tried to advance the pusher into the ureter, the distal end of the stent was ripped/torn and buckled.The procedure was successfully completed with another polaris ultra 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 good.A photo of the complaint device was provided and showed that the distal end of the stent was ripped/torn and buckled.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopic lithotripsy procedure in the ureter performed on march 22, 2021.During the procedure, inside the patient, when the physician tried to advance the pusher into the ureter, the distal end of the stent was ripped/torn and buckled.The procedure was successfully completed with another polaris ultra 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 good.A photo of the complaint device was provided and showed that the distal end of the stent was ripped/torn and buckled.
Additional Manufacturer Narrative
Block h6: medical device code a0414 captures the reportable event of stent torn inside the patient.Medical device code a040601 captures the reportable event of stent buckled inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the proximal (bladder pigtail and suture hole) section was torn.The suture string was not returned with the device.No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the bladder pigtail and suture hole of the ureteral stent was torn.The failure found (suture hole torn) is a problem that could have been generated by the user or due to the interaction of the device with the suture string.Additionally, the suture string was not returned and the device was outside the original pouch.During the product analysis, no buckled defects or issues were identify.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11655760
• Report Number: 3005099803-2021-01647
• Device Sequence Number: 3610058
• Product Code: FAD
• UDI-Device Identifier: 08714729124306
• UDI-Public: 08714729124306
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 08/04/2023
• Device Model Number: M0061921220
• Device Catalogue Number: 192-122
• Device Lot Number: 0025809494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1