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

Model Number	M0061552220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 polaris loop stent was used during a ureteral stenting procedure in the ureter, performed on (b)(6) 2019.According to the complainant, during unpacking, the physician noticed that the stent was broken in two along the shaft.The procedure was successfully completed with another polaris loop stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block f10; h6: problem code and device code 1069 captures the reportable event of stent shaft broken.Block h10: a polaris loop was returned for analysis.A visual evaluation of the returned device revealed the shaft of the stent and one loop was detached.The suture string and one loop were not returned for evaluation.No other issues were noted.The stent returned without the suture string and without one loop, it is evidence of the stent was manipulated.The failure found (stent detached) is an issue that could have been generated by the user or due to the interacting of the device with the suture string.Therefore, "adverse event related to procedure" is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop stent was used during a ureteral stenting procedure in the ureter, performed on (b)(6) 2019.According to the complainant, during unpacking, the physician noticed that the stent was broken in two along the shaft.The procedure was successfully completed with another polaris loop stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.

• 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: 8794131
• Report Number: 3005099803-2019-03611
• Device Sequence Number: 13911486
• Product Code: FAD
• UDI-Device Identifier: 08714729421023
• UDI-Public: 08714729421023
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 07/02/2021
• Device Model Number: M0061552220
• Device Catalogue Number: 155-222
• Device Lot Number: 0022333115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 73