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

Model Number	M0061921440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Study: (b)(6) clinical study.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was implanted during a stent placement procedure for stone placement management and laser lithotripsy in the left distal ureter on (b)(6) 2021 as part of the (b)(6) clinical study.On (b)(6) 2021, a planned stent removal was performed.The implanted stent was successfully removed with no difficulty via a cyto/grasper in the operating room.Oral pain control was given to the patient.There was no new device implanted.The patient's condition following the removal procedure is reported to be stable.On (b)(6) 2021, the patient was hospitalized due to a urinary tract infection.The patient was given antibiotics and hospitalized overnight due to the urinary tract infection.The event was considered to be resolved as of (b)(6) 2021 and was discharged from the hospital.In the physician's assessment, the relationship between the procedure and the urinary tract infection is unlikely related and the relationship between the device and the urinary tract infection is possible.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11930101
• Report Number: 3005099803-2021-02642
• Device Sequence Number: 4381141
• Product Code: FAD
• UDI-Device Identifier: 08714729124580
• UDI-Public: 08714729124580
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2023
• Device Model Number: M0061921440
• Device Catalogue Number: 192-144
• Device Lot Number: 0025435406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR