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

Model Number	M0061552220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code a0401 captures the reportable event of stent shaft break.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a holmium laser lithotomy for right renal stones under flexible ureteroscope procedure in the kidney, performed on (b)(6) 2021.During unpacking, it was noticed that the stent was fractured in the middle of the device and could not be used.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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a holmium laser lithotomy for right renal stones under flexible ureteroscope procedure in the kidney, performed on (b)(6) 2021.During unpacking, it was noticed that the stent was fractured in the middle of the device and could not be used.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 ureteral was analyzed, and a visual evaluation noted that the shaft was torn.The suture did not returned.No other issues with the device were noted.The reported event was confirmed.According to product analysis, it is possible that operational factors, interaction of the device with the suture string such as entanglement, manipulation or excess of force applied during it use, could have caused the detached 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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a holmium laser lithotomy for right renal stones under flexible ureteroscopy procedure in the kidney, performed on (b)(6) 2021.During unpacking, it was noticed that the stent was fractured in the middle of the device and could not be used.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 ureteral was analyzed, and a visual evaluation noted that the shaft was torn.The suture did not returned.No other issues with the device were noted.The reported event was confirmed.According to product analysis, it is possible that operational factors, interaction of the device with the suture string such as entanglement, manipulation or excess of force applied during it use, could have caused the detached 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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 13472811
• Report Number: 3005099803-2022-00465
• Device Sequence Number: 3872111
• 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,Followup
• Report Date (Section B): 04/11/2022

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: 11/21/2022
• Device Model Number: M0061552220
• Device Catalogue Number: 155-222
• Device Lot Number: 0024815824
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 02/18/2022; 03/17/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/17/2022; 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2019
• 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: 38 YR
• Patient Sex: Male
• Patient Weight: 75 KG