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

Model Number	M0061921210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was open to be used during a stent exchange procedure performed in the right ureter on (b)(6) 2020.According to the complainant, during preparation, outside the patient, when the suture was removed, the lower segment of the stent shaft broke.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.
Event or Problem Description
It was reported to boston scietific corporation that a polaris ultra ureteral stent was open to be used during a stent exchange procedure performed in the right ureter on (b)(6)2020.According to the complainant, during preparation, outside the patient, when the suture was removed, the lower segment of the stent shaft broke.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.
Additional Manufacturer Narrative
Block h6: device code 1069 captures the reportable event of stent shaft broken.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the stent shaft proximal section was detached.The suture string was returned un-loaded and properly cut.No other issues with the device were noted.The reported event was confirmed.Based on the product analysis, the suture string was returned un-loaded and properly cut, evidence that the stent was manipulated.The failure found, stent shaft proximal section (next to bladder pigtail) detached, is an issue that could have been generated by the user or due to the interaction of the device with the suture string.The most probable root cause is adverse event related to procedure since it is most likely 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: 10420956
• Report Number: 3005099803-2020-03410
• Device Sequence Number: 3872484
• Product Code: FAD
• UDI-Device Identifier: 08714729124283
• UDI-Public: 08714729124283
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 10/14/2022
• Device Model Number: M0061921210
• Device Catalogue Number: 192-121
• Device Lot Number: 0024602385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR