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

Model Number	155-233
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).A visual analysis of the returned product revealed that the returned stent was received with the distal section (stent shaft) detached and one loop was detached and not returned with the device.The stent was returned with the distal section (stent shaft) detached, also, one loop detached; consequently, confirming the reported complaint.It is important to mention the suture was returned unloaded and properly cut and the protective tube was loaded in the stent.The device history record review was performed and no anomalies were observed, the review confirmed that the device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.Additionally, the stent returned with the suture string properly cut and the protective tube loaded, it is evidence that the stent was manipulated.Therefore, the failures found (loop detached and distal section detached) are issues that could have been generated by the user or due to the interacting of the device with the suture string.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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop stent was used during a ureteral replacement procedure performed on (b)(6) 2019.According to the complaint during the procedure the coil was detached at the end of the stent.The procedure was completed with a different device and model.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.This event has been deemed reportable based on the investigation results; distal section (shaft stent) detached.

• Brand Name: POLARIS LOOP
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 9175035
• Report Number: 3005099803-2019-04945
• Device Sequence Number: 19526755
• Product Code: FAD
• UDI-Device Identifier: 08714729421092
• UDI-Public: 08714729421092
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 10/24/2021
• Device Model Number: 155-233
• Device Catalogue Number: 155-233
• Device Lot Number: 0022847400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1