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

Model Number	M0061552330
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteroscopic endoprosthesis placement procedure in the left ureter, performed on (b)(6), 2022.During the procedure and inside the patient, it was noted that the stent was broken in half along the shaft when the guidewire was retracted while attempting to deploy the stent.Another polaris loop ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteroscopic endoprosthesis placement procedure in the left ureter, performed on (b)(6) 2022.During the procedure and inside the patient, it was noted that the stent was broken in half along the shaft when the guidewire was retracted while attempting to deploy the stent.Another polaris loop ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
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 stent was analyzed, and a visual evaluation noted that the shaft was detached.It was also observed that the stent shaft was buckled/accordion.The suture and the positioner were not returned for analysis.For functional inspection, a mandrel of 0,039" was used and it passed through the stent successfully.During the magnification, it was observed that the distal end of the shaft torn.No other problems with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.According to the product analysis, the device was found with the shaft detached and torn, as well as buckled/accordion.Additionally, according to the event description which states "the stent was fractured when the guide wire was retracted after the internal stent was placed", it is possible to conclude that operational factors, interaction of the excess of force applied over the device during the procedure, such as the handling/manipulation during the placement of the device could have caused the failures that was observed.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: 15738570
• Report Number: 3005099803-2022-06398
• Device Sequence Number: 17733629
• Product Code: FAD
• UDI-Device Identifier: 08714729421092
• UDI-Public: 08714729421092
• 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): 12/30/2022

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: 11/16/2024
• Device Model Number: M0061552330
• Device Catalogue Number: 155-233
• Device Lot Number: 0028404132
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG