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

Model Number	M0061921330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code a0401 captures the reportable event of stent shaft break.Impact code f23 captures the reportable event of unexpected medical intervention.Block e1: (b)(6).
Event or Problem Description
It was reported that the stent was broken into two pieces along the shaft.The broken stent was removed from the patient.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code a0401 captures the reportable event of stent shaft break.Impact code f23 captures the reportable event of unexpected medical intervention.Block e1: health care facility name: (b)(6).Health care facility address: (b)(6).Block h11; correction to block d4: model number.
Event or Problem Description
It was reported that the stent was broken into two pieces along the shaft.The broken stent was removed from the patient.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.

• 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: 19716627
• Report Number: 2124215-2024-42411
• Device Sequence Number: 18211375
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0033167617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/20/2024
• Date Device Manufactured: 01/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown