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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TVA MEDICAL, INC. WAVELINQ ENDOAVF SYSTEM; ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
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TVA MEDICAL, INC. WAVELINQ ENDOAVF SYSTEM; ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE Back to Search Results
Model Number FX-001CE
Medical Device Problem Code Failure to Align (2522)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As a result of the acquisition of tva medical, inc., on (b)(6) 2018 a retrospective review was completed on (b)(6) 2018.Based on (b)(4) procedures and 21 cfr part 803 regulation this event is classified as an mdr reportable event.
 
Event or Problem Description
It was reported that after the devices were successfully inserted and navigated to the target lesion, the devices allegedly failed to align properly.It was further reported that the health care provider made the decision to attempt to create the fistula, however, no fistula was created.There was no reported patient injury.
 
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Brand Name
WAVELINQ ENDOAVF SYSTEM
Common Device Name
ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
Manufacturer (Section D)
TVA MEDICAL, INC.
7000 bee cave road
suite 250
austin TX 78746
MDR Report Key8567555
Report Number3011392541-2019-00007
Device Sequence Number2349215
Product Code PQK
UDI-Device Identifier00868260000211
UDI-Public(01)00868260000211
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
DEN160006
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/30/2019
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 Health Professional
Device Model NumberFX-001CE
Device Catalogue NumberFX-001CE
Device Lot NumberS0036
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/01/2018
Initial Report FDA Received Date04/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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