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

Model Number	M006155231090
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).(b)(4).The returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that the device was damaged.The stent was detached at proximal section and one loop was ripped/torn.The suture string was returned cut and loaded in the loop in good condition and the positioner returned and was found in good condition.A photo was attached in the record and it observed the stent shaft middle section detached and one loop ripped/torn, positioner and the suture string inside of the pouch; it is important to mention that the stabilizer was not observed loaded in the device.The reported event was confirmed.According to product analysis, the suture string returned untied and the device was received out of original package, it is evidence of the stent was manipulated.The problems found are issues that could have been generated by the user or due to the interacting of the device with the suture string during preparation.One loop of the stent was ripped/torn and the failure found is consistent when the suture is being pulled with an excess of force and the defect was noted in the bladder side of the device specifically in one loop where the suture goes placed.Thereofre, adverse event related to procedure, is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a stent replacement procedure in the urinary tract, performed on (b)(6) 2021.During unpacking, the stent loop was found to be torn.Another polaris loop ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent shaft detached/separated.

• 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: 12289126
• Report Number: 3005099803-2021-03846
• Device Sequence Number: 20001588
• Product Code: FAD
• UDI-Device Identifier: 08714729765493
• UDI-Public: 08714729765493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/06/2021

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: 03/24/2022
• Device Model Number: M006155231090
• Device Catalogue Number: 155-231-09
• Device Lot Number: 0024024589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1