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	08/20/2018
Type of Reportable Event	Serious Injury
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 bdpi internal procedures and 21 cfr part 803 regulation this event is classified as an mdr reportable event.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that after successfully creating an arteriovenous fistula (avf) in the ulnar artery and vein, the fistula was identified closed during the 0-10 day follow up, and an alleged pseudoaneurysm was also observed.Reportedly, the pseudoaneurysm resolved without requiring any treatment.

• 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: 8563095
• Report Number: 3011392541-2019-00005
• Device Sequence Number: 2192007
• Product Code: PQK
• UDI-Device Identifier: 00868260000211
• UDI-Public: (01)00868260000211
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: DEN160006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX-001CE
• Device Catalogue Number: FX-001CE
• Device Lot Number: S0040
• 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 Date: 04/29/2019
• 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: Other