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

Model Number	M0061552230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a lithotripsy procedure in the kidney, performed on (b)(6) 2022.During preparation, it was found that the body of the stent was damaged.Another polaris loop ureteral stent was opened and successfully completed the procedure.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.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Block h10: the returned polaris loop was analyzed, and a visual evaluation noted that the stent shaft was detached.It was observed that 1 loop is detached/separated and both loops were found torn.Additionally, the suture returned was loaded and uncut, and the positioner was returned in good conditions.For the functional test use a mandrel of 0.039" and pass through the stent without resistance.Finally, during magnification observed closely that section where the device was detached and observed several torn in both loops.No other problems with the device were noted.The reported event was confirmed.According to the product analysis, it was found that device has their shaft detached and several tears in both loops.Additionally, found their suture loaded and uncut.Most likely, it is possible that operational factors, handling/manipulation and/or an interaction of excess force during interaction with the suture string such as an entanglement before their use could have caused the found issues that was observed.Consequently, affect the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a lithotripsy procedure in the kidney, performed on (b)(6) 2022.During preparation, it was found that the body of the stent was damaged.Another polaris loop ureteral stent was opened and successfully completed the procedure.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.

• Brand Name: POLARIS LOOP
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15609994
• Report Number: 3005099803-2022-06028
• Device Sequence Number: 7169970
• Product Code: FAD
• UDI-Device Identifier: 08714729421030
• UDI-Public: 08714729421030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: 02/02/2025
• Device Model Number: M0061552230
• Device Catalogue Number: 155-223
• Device Lot Number: 0028804308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 60 KG