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

Model Number	M0061552330
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a previously implanted polaris loop ureteral stent was removed from a patient during a ureteral stent replacement procedure performed in the ureter.The exact date of the procedure was not reported.On (b)(6) 2020, approximately one to two months after the stent was implanted, the physician performed a planned stent removal procedure.According to the complainant, during the procedure, the physician noticed that the loops of the polaris loop ureteral stent were broken.The stent was removed in its entirely from the patient and another polaris loop ureteral stent was used to successfully complete the procedure.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 stable and fine.
Additional Manufacturer Narrative
Block h6: device code 4008 captures the reportable event of stent material split, cut or torn inside the paient.Block h10: the returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that the stent was damaged with the loops ripped/torn at the proximal section and the pigtail was in good shape.The suture was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the stent loops were ripped/torn at the proximal section.Additionally, the suture was not returned for analysis, evidence that the stent was manipulated.The issue found, stent loops 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 issue found is consistent with one caused with the suture being pulled and damaged the loops as the issue was noted at the bladder side of the device, specifically the loops where the suture is placed.Therefore, the most probable cause of this complaint 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.Block h11: correction to field b5: describe event or problem based on review on (b)(6) 2021.
Event or Problem Description
It was reported that a previously implanted polaris loop ureteral stent was removed from a patient during a ureteral stent replacement procedure performed in the ureter.The exact date of the procedure was not reported.On (b)(6) 2020, approximately one to two months after the stent was implanted, the physician performed a planned stent removal procedure.According to the complainant, during the procedure, the physician noticed that the loops of the polaris loop ureteral stent were broken.The stent was removed in its entirely from the patient and another polaris loop ureteral stent was used to successfully complete the procedure.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 stable and fine.Review of record on (b)(6) 2021: it was reported to boston scientific corporation that a previously implanted polaris loop ureteral stent was removed from a patient during a ureteral stent replacement procedure performed in the ureter on (b)(6) 2020.The exact date the stent was implanted was not reported, however the polaris loop ureteral stent was reported to be implanted for one to two months.According to the complainant, during the planned stent removal procedure, the physician noticed that the loops of the polaris loop ureteral stent were broken.The stent was removed in its entirety from the patient like normal with tongs and forceps and another polaris loop ureteral stent was used to successfully complete the procedure.

• 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: 11109182
• Report Number: 3005099803-2020-06518
• Device Sequence Number: 16408862
• Product Code: FAD
• UDI-Device Identifier: 08714729421092
• UDI-Public: 08714729421092
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 04/21/2022
• Device Model Number: M0061552330
• Device Catalogue Number: 155-233
• Device Lot Number: 0023675843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1