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

Model Number	M006155232090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.Initial reporter state: (b)(6).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 loop ureteral stent was being used in an unknown procedure.The event date was not reported.According to the complainant, during procedure, while attempting to remove the implanted stent, the loop part of the stent torn.The polaris loop ureteral stent was removed without additional intervention.The procedure was successfully completed and no new stent was implanted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: initial reporter state: (b)(6).Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code 2907 captures the reportable event of stent torn material inside the patient.Block h10: the returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that the loops was ripped/torn at the proximal section.The suture was not returned with the device.No other issues with the device were noted.The reported event was confirmed.Based on product analysis, the loops were ripped/torn at the proximal section, the device was returned without the suture string, the device was outside the original pouch.Evidence that the stent was manipulated.The failure found, loops of the stent were ripped/torn, is an issue that could have been generated by the user or due to the interaction of the device with the suture string.The failure problem found is consistent with one caused with the suture being pulled and damaged the loops and the defect was noted at the bladder side of the device specifically in the loops where the suture gets placed.The most probable cause of those failures is adverse event related to procedure since it is the most likely that the adverse event occurred during the preparation and the device had no influence on event.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 polaris loop ureteral stent was being used in an unknown procedure.The event date was not reported.According to the complainant, during procedure, while attempting to remove the implanted stent, the loop part of the stent torn.The polaris loop ureteral stent was removed without additional intervention.The procedure was successfully completed and no new stent was implanted.There were no patient complications reported as a result of this event.

• Brand Name: POLARIS LOOP
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10839779
• Report Number: 3005099803-2020-05348
• Device Sequence Number: 17179042
• Product Code: FAD
• UDI-Device Identifier: 08714729765516
• UDI-Public: 08714729765516
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030503
• 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): 12/07/2020

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 Model Number: M006155232090
• Device Catalogue Number: 155-232-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1