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

Model Number	M0061552230
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the stent fractured when it was pushed out.The procedure was completed with another of same device and no patient complications reported.The patient's condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the stent shaft was broken, therefore this event has been deemed an mdr reportable event.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Imdrf medical device code a0501 captures the reportable investigation results of stent shaft broken.The returned polaris loop ureteral stent was analyzed, and upon magnification it was observed that the shaft was detached.Additionally, the suture was not returned.No other problems with the device were noted.The reported event was not confirmed.With all the available information, boston scientific concludes that the reported event was not confirmed.It is possible to concluded that this issue could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get detached during the procedure affecting 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.
Additional Manufacturer Narrative
Block h6: imdrf medical device code a0501 captures the reportable investigation results of stent shaft broken.Update to block h11: the returned polaris loop ureteral stent was analyzed, and upon magnification it was observed that the shaft was detached.Additionally, the suture was not returned.No other problems with the device were noted.The reported event was not confirmed.With all the available information, boston scientific concludes that the reported event was not confirmed.Regarding to the analysis performed to the returned device, evidence stent coil detachment was not confirmed, due the loop was not detached to the shaft and there was no more evidence related to this kind of reported allegation.Therefore, the cause code will be no problem detected.For the reported event of stent detached or separated.It is possible to conclude that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get detached during the procedure affecting 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 during the procedure, the stent fractured when it was pushed out.The procedure was completed with another of same device and no patient complications reported.The patient's condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the stent shaft was broken, therefore this event has been deemed an mdr reportable event.Please see block h11 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19834079
• Report Number: 2124215-2024-44845
• Device Sequence Number: 12419122
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 06/15/2026
• Device Model Number: M0061552230
• Device Catalogue Number: 155-223
• Device Lot Number: 0031834677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG