MAUDE Adverse Event Report: TVA MEDICAL, INC. WAVELINQ ENDOAVF SYSTEM; ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE

Model Number	FX-001CE
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was not provided, a review of the device history records has not been performed.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during an attempt to create the arteriovenous fistula (avf), the venous catheter electrode allegedly failed to cut the tissue although it was properly align with the arterial catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history review was performed with the reported lot number.This lot meets all release criteria.A manufacturing records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: a sample evaluation was performed and catheters attract to each other and were coapted.Tissue cutting test was performed with porcine carotid artery; device was able to cut tissue.Tissue cut was measured and found to be approximately 0.4cm in length.The investigation results are unconfirmed as the device performed as expected under functional testing.The root cause could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g4, d4 (expiry date: 11/2019).
Event or Problem Description
It was reported that during an attempt to create the arteriovenous fistula (avf), the venous catheter electrode allegedly failed to cut the tissue although it was properly align with the arterial catheter.There was no reported patient injury.

• 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 Key: 9386189
• Report Number: 3011392541-2019-00011
• Device Sequence Number: 16699012
• Product Code: PQK
• UDI-Device Identifier: 00868260000211
• UDI-Public: (01)00868260000211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: DEN160006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: Health Professional
• Device Model Number: FX-001CE
• Device Catalogue Number: FX-001CE
• Device Lot Number: S0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1