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

Model Number	M006155231090
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a procedure, performed on (b)(6) 2021.Post procedure, it was noticed that the stent was completely obstructing the right ureter at distal end.No drainage was seen and the contrast from computerized tomography (ct) 8 hours prior, was still present at time of surgery.On (b)(6) 2021, a procedure was performed to remove the polaris loop ureteral stent.The ureteral stent was removed in its entirely and a 4.8f percuflex ureteral stent was implanted and successfully completed the procedure.Obstruction in the ureter was reported as a result of this event.The patient's condition at the conclusion of the procedure was reported have fully recovered and to be fine.

• 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: 12417930
• Report Number: 3005099803-2021-04444
• Device Sequence Number: 17324469
• Product Code: FAD
• UDI-Device Identifier: 08714729765493
• UDI-Public: 08714729765493
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M006155231090
• Device Catalogue Number: 155-231-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention