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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION POLARIS ULTRA; STENT, URETERAL Back to Search Results
Model Number M0061921320
Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Patient Problems Discomfort (2330); Insufficient Information (4580)
Event Date 03/10/2024
Event Type  Injury  
Event Description
Note: this report is one of two complaints that pertain to the same event (mfr report #2124215-2024-19098 and mfr.Report #2124215-2024-19110).It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible ureterolithomy procedure performed on (b)(6) 2024.During the procedure, the stent did not pass through the guidewire.It was noted that the stent was buckled.The stent was soaked in water for approximately 5 to 10 minutes, however, due to the failure to pass, it had to be removed.The procedure had to be canceled because the patient became complicated, and discomfort was experienced.It was noted that the discomfort experienced was from the specialists with the product problem.There were no additional patient complications reported.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent buckled material, inside the patient.Imdrf impact code f05 captures the reportable event of delay to treatment.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent buckled material, inside the patient.Imdrf impact code f05 captures the reportable event of delay to treatment.Update to block f10, block h6: discomfort.
 
Event Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible ureterolithomy procedure performed on (b)(6) 2024.During the procedure, the stent did not pass through the guidewire.It was noted that the stent was buckled.The stent was soaked in water for approximately 5 to 10 minutes, however, due to the failure to pass, it had to be removed.The procedure had to be canceled because the patient became complicated, and discomfort was experienced.It was noted that the discomfort experienced was from the specialists with the product problem.There were no additional patient complications reported.
 
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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
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key19053008
MDR Text Key339548197
Report Number2124215-2024-19098
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729124429
UDI-Public08714729124429
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K010002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/14/2024
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 NumberM0061921320
Device Catalogue Number192-132
Device Lot Number0031883408
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received04/05/2024
Supplement Dates Manufacturer Received04/23/2024
Supplement Dates FDA Received05/14/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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