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

Model Number	M0061552420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a transureteroscopic lithotripsy procedure in the ureter, performed on (b)(6) 2023.During unpacking, it was found that the stent was fractured.Another polaris ultra ureteral stent was opened and used 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
Imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a transureteroscopic lithotripsy procedure in the ureter, performed on (b)(6) 2023.During unpacking, it was found that the stent was fractured.Another polaris ultra ureteral stent was opened and used 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: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a transureteroscopic lithotripsy procedure in the ureter, performed on (b)(6) 2023.During unpacking, it was found that the stent was fractured.Another polaris ultra ureteral stent was opened and used 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: imdrf device code a0401 captures the reportable event of stent shaft break.Block h10: the returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that the stent shaft and both loops were detached.The positioner and the suture were not returned.A photo of the device was also attached, and it was observed that the stent shaft and the loops were detached.A functional analysis was performed, a mandrel of 0,039" was used and it passed through the stent without resistance.No other problems with the device were noted.The reported event was confirmed.Based on all the gathered information, the stent shaft and both loops detached, and the suture not returned indicates that it was removed, and the stent was used.According to the evidence, it is possible that operational factors, interaction of the excess force during interaction with the suture string such as an entanglement before their use could have caused the detachments that was observed.Consequently, this affects the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.

• 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: 16463217
• Report Number: 3005099803-2023-01068
• Device Sequence Number: 16757931
• Product Code: FAD
• UDI-Device Identifier: 08714729421146
• UDI-Public: 08714729421146
• 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): 05/01/2023

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: 12/19/2024
• Device Model Number: M0061552420
• Device Catalogue Number: 155-242
• Device Lot Number: 0028589437
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 02/09/2023; 04/05/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/09/2023; 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 70 KG