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

Model Number	M0061552230
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of stent buckled material inside the patient.Imdrf device code a0414 captures the reportable event of stent torn material inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteral stent placement procedure in the ureter, performed on (b)(6) 2023.During the procedure and inside the patient, it was noticed that the stent cracked at the tail end probably caused by ureteral stones.Another polaris loop ureteral stent was opened and used to successfully complete 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.A photo of the complaint device was provided and showed that the stent was buckled and torn.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteral stent placement procedure in the ureter, performed on (b)(6) 2023.During the procedure and inside the patient, it was noticed that the stent cracked at the tail end probably caused by ureteral stones.Another polaris loop ureteral stent was opened and used to successfully complete 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.A photo of the complaint device was provided and showed that the stent was buckled and torn.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of stent buckled material inside the patient.Imdrf device code a0414 captures the reportable event of stent torn material inside the patient.Block h10: the returned polaris loop ureteral stent was analyzed, and a photo of the device was provided.A visual evaluation noted that the stent shaft was buckled/accordion and torn.No other problems with the device were noted.The reported event was confirmed.Based on the product analysis, it is possible to conclude that most likely, the problem was caused due to the excess force that was applied over the device when setting up, probably at the time when it was tried to be inserted into the guidewire.It could also be caused by ureteral stone such as handling of the device during preparation, affecting the performance of the device.Therefore, adverse event related to procedure is selected as the most probable cause for this complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 17085334
• Report Number: 3005099803-2023-02944
• Device Sequence Number: 2773620
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 09/22/2025
• Device Model Number: M0061552230
• Device Catalogue Number: 155-223
• Device Lot Number: 0030204609
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG