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

Model Number	M0061552320
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device code a0401 captures the reportable event of stent shaft broken.
Event or Problem Description
It was reported that a polaris loop ureteral stent was used during a rigid ureteroscopy lithotomy procedure in the ureter performed on (b)(6) 2022.During the procedure, it was noted that the stent could not cross the lesion.It was found that the stent became fractured.The procedure was successfully completed with another polaris loop ureteral stent.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 code a0401 captures the reportable event of stent shaft broken.Block h10: the returned polaris loop ureteral stent was analyzed, and a visual evaluation noted both that both loops were detached.Additionally, the suture returned unloaded and cut.For the functional test, used of a mandrel of 0.039, and the stent passed through without resistance.No other problems with the device were noted.The reported event was not confirmed.Based on the most relevant information of the complaint event description and device analysis, it was found that both loops were detached.Also, the suture returned unloaded and cut, evidence that the suture was removed and the stent was used.It is possible during the operational factors interacting with the suture string, excess of force applied such as an entanglement during their use in the procedure could have caused the detachment.Consequently, affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported that a polaris loop ureteral stent was used during a rigid ureteroscopy lithotomy procedure in the ureter performed on (b)(6) 2022.During the procedure, it was noted that the stent could not cross the lesion.It was found that the stent became fractured.The procedure was successfully completed with another polaris loop ureteral stent.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 information received that the fractured was found during unpacking and occurred outside the patient.It was noted that the device could not be used.

• 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: 16195805
• Report Number: 3005099803-2023-00063
• Device Sequence Number: 5971551
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: 08714729421085
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 06/24/2024
• Device Model Number: M0061552320
• Device Catalogue Number: 155-232
• Device Lot Number: 0027561216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 65 KG