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

Model Number	M0061552320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was attempted to be used during a lithotripsy via ureteroscope procedure for the treatment of stones in the right kidney performed on (b)(6), 2023.During unpacking, the stent was found 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.A photo of the complaint device was provided and showed that the stent shaft was broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a stent shaft broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a stent shaft broken.Correction to block d4: model number update to block g1 for manufacturer contact person block h10: the returned polaris ureteral stent was analyzed, and a visual and media evaluation noted that the shaft was detached.During magnification, it was observed closely that the shaft was detached, and the suture loaded in the loops.No other problems with the device were noted.The reported event of stent shaft detached was confirmed.Taking all available information into consideration, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Based on the analysis performed to the returned device, it is possible to conclude that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get detached during the preparation affecting the performance of the device.Consequently, affect the performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was attempted to be used during a lithotripsy via ureteroscope procedure for the treatment of stones in the right kidney performed on (b)(6) 2023.During unpacking, the stent was found 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.A photo of the complaint device was provided and showed that the stent shaft was broken.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17804329
• Report Number: 3005099803-2023-05016
• Device Sequence Number: 7183739
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 10/03/2025
• Device Model Number: M0061552320
• Device Catalogue Number: 155-232
• Device Lot Number: 0030274240
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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: 75 KG