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

Model Number	M006192132090
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).(b)(4).
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used during procedure.The event date was not reported.It was noted that the stent was detached.The procedure was successfully completed with another polaris ultra 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 as no patient injury.
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Block h11: block h6 device code has been corrected from stent shaft broken (a0401) to coil detached (a0501) based on the response provided from the sales rep stated that it seems that the coil was detached from the stent.Boston scientific no longer considers this to be a reportable event.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used during procedure.The event date was not reported.It was noted that the stent was detached.The procedure was successfully completed with another polaris ultra 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 as no patient injury.
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Block h11: block h6 device code has been corrected from stent shaft broken (a0401) to coil detached (a0501) based on the response provided from the sales rep stated that it seems that the coil was detached from the stent.Boston scientific no longer considers this to be a reportable event.Block h10: the returned polaris ultra ureteral stent was returned, and a visual evaluation noted that the bladder coil was detached.Additionally, the suture was not returned.The positioner and the detached part were not returned.A functional test was performed and was noted that the stent passes through without resistance.No other problem with the device were noted.The reported event of was not 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.For the reported issue of stent shaft.Break, it is not confirmed due to a breakage in their shaft and was not detected during the analysis and neither a related issue with the reported allegation, additionally, the device was found detached in their bladder coil and not a breakage.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 ultra ureteral stent was used during procedure.The event date was not reported.It was noted that the stent was detached.The procedure was successfully completed with another polaris ultra 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 as no patient injury.

• 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: 16215586
• Report Number: 3005099803-2023-00088
• Device Sequence Number: 7492474
• Product Code: FAD
• UDI-Device Identifier: 08714729124436
• UDI-Public: 08714729124436
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2023

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: 05/05/2025
• Device Model Number: M006192132090
• Device Catalogue Number: 192-132-09
• Device Lot Number: 0030139922
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 02/22/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/07/2023; 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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