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

Model Number M006192132090

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

Patient Problems Pain (1994); Urinary Retention (2119); Discomfort (2330); Dysuria (2684)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was discarded 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was successfully implanted during a ureteroscopy with lithotripsy procedure in the bladder performed on (b)(6) 2021.Post procedure, the patient had a discomfort in the bladder was transmitted to the kidney and then to the rectum as a nerve stimulation.It was reported that the patient had dysuria while using the stent for a very short period of time and after 1 month, becoming more continuous in a short period of time.The stent was successfully removed and all the pain disappeared including dysuria, discomfort in kidney, rectum and bladder.There were no new stents implanted.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 12546577
• MDR Text Key: 273768516
• Report Number: 3005099803-2021-04978
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124436
• UDI-Public: 08714729124436
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/29/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: M006192132090
• Device Catalogue Number: 192-132-09
• Device Lot Number: 0025661517
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2020
• 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: 34 YR