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

Model Number	M0061921340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).(b)(4).The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a cysto retrograde pyelogram, cystoscopy left retrograde ureterogram with left ureteroscopy and left double j stent placement, ureteroscopy procedure in the left ureter performed on (b)(6) 2021.The stent was successfully implanted without any problems.On (b)(6) 2021, post procedure, it was noted that a highly rare bacteria was detected in the patient's urine.It was not confirmed if the implanted stent could be an underlying contributing factor.A bacteria that grew from urine culture was raoultella planticola and the patient was placed on macrobid.It was reported that the patient was given with oral antibiotics by community physician.The stent was successfully removed from the patient at the other facility and there were no new stent implanted.The patient remained as an outpatient and stable.

• 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: 12424507
• Report Number: 3005099803-2021-04458
• Device Sequence Number: 3420766
• Product Code: FAD
• UDI-Device Identifier: 08714729124467
• UDI-Public: 08714729124467
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2024
• Device Model Number: M0061921340
• Device Catalogue Number: 192-134
• Device Lot Number: 0027087093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 83