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	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during the arteriovenous fistula (avf) creation procedure through the left medial brachial vein and left brachial artery access, the electrode allegedly was unable to cut the tissue.Therefore, the catheters were removed from the patient without incident, and a new catheter set was used to create the patient's fistula in the left medial ulnar vein and left common ulnar artery.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number for the device was provided; therefore, a device history record was performed.A manufacturing review was also conducted and there was nothing found to indicate there was a manufacturing related cause for this event.This is the first complaint reported for the lot number to date.Investigation summary: one arterial catheter and one venous catheter were received and evaluated.A tissue cutting test was performed with the sample device on porcine carotid artery; the device was able to cut the tissue.The tissue cut was measured and found to be approximately 0.4cm.Therefore, the investigation results are unconfirmed as the device performed as expected under functional testing.Based on the available information a definite root cause could not be determined.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.H11:section a through f - 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 during the arteriovenous fistula (avf) creation procedure through the left medial brachial vein and left brachial artery access, the electrode allegedly was unable to cut the tissue.Therefore, the catheters were removed from the patient without incident, and a new catheter set was used to create the patient's fistula in the left medial ulnar vein and left common ulnar artery.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: 8713001
• Report Number: 3011392541-2019-00008
• Device Sequence Number: 2663513
• Product Code: PQK
• UDI-Device Identifier: 00868260000211
• UDI-Public: (01)00868260000211
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/06/2020

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: S0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1