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

Model Number	M0061921310
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was opened to be used during a ureteroscopy procedure performed on (b)(6) 2024.During preparation.The device tip was found sticky.It was noted that the packaging was normal.The procedure was successfully completed with another polaris ultra ureteral stent.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 ultra ureteral stent was opened to be used during a ureteroscopy procedure performed on (b)(6) 2024.During preparation.The device tip was found sticky.It was noted that the packaging was normal.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual and microscopic evaluation noted that the bladder coil detached, and the suture hole torn.There was not possible to see any foreign material in the pouch.No other problems with the device were noted.The reported event was not confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.For the reported problem of packaging foreign material, it is not confirmed due to a foreign material was not detected in the pouch during the analysis.For this reason, the as analyze code will be no problem detected.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 and torn during the preparation 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.

• Brand Name: POLARIS ULTRA
• 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: 18965351
• Report Number: 2124215-2024-15880
• Device Sequence Number: 20809894
• Product Code: FAD
• UDI-Device Identifier: 08714729124405
• UDI-Public: 08714729124405
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K010002
• 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
• Report Date (Section B): 05/07/2024

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: 08/22/2026
• Device Model Number: M0061921310
• Device Catalogue Number: 192-131
• Device Lot Number: 0032275683
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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: 70 YR
• Patient Sex: Female