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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 in a ureteral stent placement procedure in the ureter performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, it was noticed that the loops were broken right after the stent was successfully placed in the target anatomy location.This resulted in the loops becoming four threads instead of two loops.The torn polaris loop ureteral stent remained implanted in the patient.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.

• 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: 11123716
• Report Number: 3005099803-2020-06585
• Device Sequence Number: 3966770
• 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 Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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: 04/21/2023
• Device Model Number: M0061552330
• Device Catalogue Number: 155-233
• Device Lot Number: 0025458373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1