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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION POLARIS LOOP; STENT, URETERAL Back to Search Results
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.
 
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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 Key15908667
MDR Text Key308127620
Report Number3005099803-2022-07044
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729421085
UDI-Public08714729421085
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K030503
Number of Events Reported1
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 NumberM0061552320
Device Catalogue Number155-233
Device Lot Number0028832694
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2022
Initial Date FDA Received12/02/2022
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 Number1
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