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

Model Number	M0061552220
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a ureteroscopy procedure, the stent became buckled and was removed from the patient.The procedure was completed with another polaris loop stent.There were no patient complications reported as a result of this event.The condition of the patient after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrd device code 040601 captures the reportable event of stent buckled.Block e1: initial reporter facility name: (b)(6) university.
Additional Manufacturer Narrative
Block h6: imdrd device code 040601 captures the reportable event of stent buckled.Block e1: initial reporter facility name: (b)(6) hospital.Block h11: the returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that the shaft was detached.The reported complaint was not confirmed; however, the shaft was found detached.Additionally, the suture did not return indicating that it was removed, and the device was used.These problems could have been caused due to an interaction of the device with the suture string such as entanglement in the shaft, manipulation or excess of force applied over the device during the setting up.Consequently, affects the performance of the device.Furthermore, the suture string/retrieval line is intended to be removed before procedure.The ifu states, the following: "retrieval line management options c.The line may be removed before stent placement.The retrieval line may be cut prior to stent placement.Remove the retrieval line by holding the knot, cutting one strand, and while holding the knot, gently pull out the retrieval line".According to the time of event, it occurred in the preparation meaning that the suture must have been cut and gently removed, however, the evidence shows the contrary with the found problem.Therefore.The compiled information on this investigation determines that the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported that, during a ureteroscopy procedure, the stent became buckled and was removed from the patient.The procedure was completed with another polaris loop stent.There were no patient complications reported as a result of this event.The condition of the patient after 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19363776
• Report Number: 2124215-2024-29873
• Device Sequence Number: 3851700
• Product Code: FAD
• UDI-Device Identifier: 08714729421023
• UDI-Public: 08714729421023
• 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): 07/12/2024

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: 07/03/2026
• Device Model Number: M0061552220
• Device Catalogue Number: 155-222
• Device Lot Number: 0031942064
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• 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: 60 YR
• Patient Sex: Male