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

Model Number	M006192133090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent replacement procedure in the ureter, performed on (b)(6) 2022.During the procedure, it was noted that the stent shaft was detached or separated.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.The device has not been returned for analysis.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent replacement procedure in the ureter, performed on (b)(6), 2022.During the procedure, it was noted that the stent shaft was detached or separated.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: medical device code a0401 captures the reportable event of stent shaft broken.Block h10: the returned polaris ureteral stent was analyzed, and a visual evaluation noted that the stent shaft was detached.Additionally, the suture, positioner and detached part was not returned.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.Regarding to all gathered information and after the device analysis, it was found that the stent shaft was detached.Most likely the interaction, handling and manipulation of the device with other device with excess of force applied, such as the operational factors during the procedure, could have generated the detachment observed.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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15611286
• Report Number: 3005099803-2022-05844
• Device Sequence Number: 15248604
• Product Code: FAD
• UDI-Device Identifier: 08714729124450
• UDI-Public: 08714729124450
• 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,Followup
• Report Date (Section B): 12/07/2022

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: 04/01/2025
• Device Model Number: M006192133090
• Device Catalogue Number: 192-133-09
• Device Lot Number: 0029707910
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2022
• 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