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

Model Number M0061921330

Device Problems Calcified (1077); Difficult to Remove (1528)

Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Discomfort (2330); Hematuria (2558)

Event Date 05/20/2023

Event Type  Injury  

Event Description

It was reported to boston scientific that a polaris ultra ureteral stent was successfully implanted in the right ureter during a ureteral calculi procedure to dilate the ureter due to ureteral stenosis on (b)(6) 2023.On (b)(6) 2023, the patient experienced distended pain in the lower abdomen after urination, occasional gross hematuria, urgent urination, and other discomfort.As a result, she came to the hospital for a re-examination.During an unplanned stent removal procedure, it was discovered that the bladder part of the stent was full of stones, and the ureter stent was difficult to remove.The stent was pulled out after crushing the stone with a pair of forceps.There was no medication given to the patient and no new stent was implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a040501 captures the reportable event of stent calcified.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e1302 captures the reportable event of hematuria.Imdrf patient code e1304 captures the reportable event of urinary urgency.Imdrf patient code e2311 captures the reportable event of discomfort.

• 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: 17176482
• MDR Text Key: 317635138
• Report Number: 3005099803-2023-03200
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2023

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 Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0028287351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: 50 YR
• Patient Sex: Female