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

Model Number M0061552320

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

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 Description

It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a percutaneous nephrolithotomy procedure in the ureter, performed on (b)(6) 2020.According to the complainant, prior to the procedure, it was noticed that the stent was fractured.Reportedly, the procedure was completed.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a percutaneous nephrolithotomy procedure in the ureter, performed on (b)(6) 2020.According to the complainant, prior to the procedure, it was noticed that the stent was fractured.Reportedly, the procedure was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code 1069 captures the reportable event of stent break.Block h10: the returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that the stent tail was damaged, one loop was ripped/torn and one loop was detached at the proximal section.The suture was not returned for analysis.No other issues with the device were noted.The reported event was not confirmed.According to the device analysis, the device as returned without the suture string.Evidence that the stent was manipulated.The failure found, loops of the stent ripped/torn and detached, is an issue that could have been generated by the user or due to the interacting of the device with the suture string.The failures found are consistent with one caused with the suture is being pulled and the damaged the loops and the defect was noted at the bladder side of the device specifically in the loops where the suture gets placed.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.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 LOOP
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10605387
• MDR Text Key: 209139856
• Report Number: 3005099803-2020-04287
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: 08714729421085
• Combination Product (y/n): N
• PMA/PMN Number: K030503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: M0061552320
• Device Catalogue Number: 155-232
• Device Lot Number: 0024497405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 71