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

Model Number	M006193132090
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2023, based on the date the manufacturer became aware of the event.Block e1: initial reporter facility name: (b)(6) hospital.Initial reporter address: (b)(6).Block h10: the returned polaris ultra ureteral stent was analyzed, a visual evaluation and magnification noted that the shaft was detached.Additionally, the suture and positioner were not returned.No other problems with the device were noted.The reported event of stent torn material was not confirmed.Taking all available information into consideration, most likely, the 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 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.Consequently, affect the performance of the device.For the reported problem of stent torn material was confirmed due to a torn was not detected during the analysis.For this reason, the as analyze code will be no problem detected.Therefore, the most probable root cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used to treat urinary lithiasis using a trans ureteral lithotripsy procedure in the urinary tract.The event date was unknown.During the procedure, the stent was found damaged.It was noted that the pigtail flap was separated.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.Investigation results revealed that the stent was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

• 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: 18279274
• Report Number: 3005099803-2023-06456
• Device Sequence Number: 12474298
• Product Code: FAD
• UDI-Device Identifier: 08714729762911
• UDI-Public: 08714729762911
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/06/2023

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: 02/26/2026
• Device Model Number: M006193132090
• Device Catalogue Number: 193-132-09
• Device Lot Number: 0031425695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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 Sex: Unknown