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

Model Number	M0061921420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteronephroscopy procedure in the right kidney, bladder, performed on (b)(6) 2021.Post procedure, on (b)(6) 2022, the patient experienced pain on the right side during urination.The physician indicated that the patient is experiencing , "a reflux of urine from the bladder to the right kidney caused by the normal process of the bladder to close when it is going to be emptied and can not be done because the stent keeps the hole always open to facilitate drainage of the kidney.When the reflux happens it causes the pain that the patient remits".Enantyun plus, modifical, and medicine for bladder contractions were given to the patient as treatment for pain.The patient's pain is beginning to decrease.The polaris ureteral stent remains implanted in the patient.It was also reported that, the diagnosis of pain was related to defects on the patient's renal system and the patient will be operated to remove the left kidney and also to remove the stent from the right ureter.

• 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: 13509987
• Report Number: 3005099803-2022-00664
• Device Sequence Number: 17455038
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: 08714729124542
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 02/10/2022

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: 05/08/2022
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Device Lot Number: 0023765260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 61 KG