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

Model Number M0061552320

Device Problems Calcified (1077); Device Stenosis (4066)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 08/11/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteral stent replacement procedure in the kidney, ureter and bladder performed on (b)(6) 2022.On (b)(6) 2022, it was noted that the patient had a follow up appointment, and it was found that the kidney, ureter and bladder show hydronephrosis.It was reported that after the lithotripsy treatment, the little crushed stone was supposed to drained through stent or urine, but the stone cant pass through the and blocked at the end of the stent.The procedure was successfully completed with another polaris loop ureteral stent.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be stable.

• Brand Name: POLARIS LOOP
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15908667
• MDR Text Key: 308127620
• Report Number: 3005099803-2022-07044
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: 08714729421085
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K030503
• 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: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061552320
• Device Catalogue Number: 155-233
• Device Lot Number: 0028832694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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