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

Model Number M0061921420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/13/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 288115720
• Report Number: 3005099803-2022-00664
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: 08714729124542
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 61 KG