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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT
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BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT Back to Search Results
Model Number FEM14060
Medical Device Problem Code Misfire (2532)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was provided; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A definite root cause for the reported event could not be determined.The device was labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem14060 fluency plus endovascular stent graft allegedly experienced misfire.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
 
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Brand Name
FLUENCY PLUS ENDOVASCULAR STENT GRAFT
Common Device Name
ENDOVASCULAR STENT GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10273474
Report Number2020394-2020-04439
Device Sequence Number14302492
Product Code PFV
UDI-Device Identifier04049519008691
UDI-Public(01)04049519008691
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/14/2020
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
Operator of Device No Information
Device Model NumberFEM14060
Device Catalogue NumberFEM14060
Device Lot NumberANCW2066
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/14/2020
Patient Sequence Number1
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