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

Model Number	FX-001CE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that post creation of the arteriovenous fistula (avf) in the ulnar-ulnar through brachial-brachial access, alleged bleeding was identified at the anastomosis going past the vein and into the arm.Reportedly, stenting was required with a covered stent to shut down the fistula/bleeding, and a surgical graft will be created at a later date.The patient did not have any issues post stenting procedure, and adequate distal flow was confirmed.The patient is currently doing well.

• 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: 9380138
• Report Number: 3011392541-2019-00010
• Device Sequence Number: 458144
• Product Code: PQK
• UDI-Device Identifier: 00868260000211
• UDI-Public: (01)00868260000211
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: FX-001CE
• Device Catalogue Number: FX-001CE
• Device Lot Number: S0049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention