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

Model Number	M0061552320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device code a0401 captures the reportable event of stent shaft broken.The returned flexima biliary delivery system was analyzed, and a visual evaluation noted the stent shaft detached.Additionally, the suture returned loaded and uncut.For the functional test, the stent passed through without resistance.Therefore, the reported complaint was confirmed.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.It was found that the stent shaft was detached.Therefore, 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 detachment that was observed.Consequently, affect the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported that a polaris loop ureteral stent was used during a ureteroscopic lithotripsy procedure in the ureter performed on (b)(6) 2022.During the preparation, it was noted that the device was found damaged and could not be used.The procedure was successfully completed with another polaris loop ureteral stent.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.This event has been deemed a reportable event based on the investigation finding of stent shaft broken.Please see additional mfr.Narrative for full investigation details.

• 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: 16206736
• Report Number: 3005099803-2023-00064
• Device Sequence Number: 5416100
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: 08714729421085
• 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
• Report Date (Section B): 01/19/2023

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: 06/24/2024
• Device Model Number: M0061552320
• Device Catalogue Number: 155-232
• Device Lot Number: 0027561216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 70 KG