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	Aneurysm (1708)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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 approximately five weeks post successful fistula creation, the patient developed an alleged aneurysm between the ulnar artery and ulnar vein requiring the patient to go into surgery for a bypass procedure.It was further alleged that there was some extravasation and spasms after the successful fistula creation procedure but, no treatment was provided.Reportedly, the patient is doing well post bypass surgery procedure.
Event or Problem Description
It was reported that approximately five weeks post successful fistula creation, the patient developed an alleged aneurysm between the ulnar artery and ulnar vein requiring the patient to go into surgery for a bypass procedure.It was further alleged that there was some extravasation and spasms after the successful fistula creation procedure but, no treatment was provided.Reportedly, the patient is doing well post bypass surgery procedure.
Additional Manufacturer Narrative
Manufacturing review: a review of manufacturing records could not be completed as the device lot number is unknown.A dhr review could not be performed as the lot number is unknown.This is the first complaint reported for this lot number to date.Investigation summary: an image review was performed.The fistula formation catheters are next to each other proximally and in appropriate position at the level of the electrode.Distally the arterial and venous catheters are close, but there remains approximately two catheters width between the magnets at the distal most magnets and key findings that the catheters appear to be in acceptable position for fistula formation.The investigation is inconclusive due to the fact that no sample was returned for evaluation.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.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.

• 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: 8501970
• Report Number: 3011392541-2019-00004
• Device Sequence Number: 2798598
• Product Code: PQK
• UDI-Device Identifier: 00868260000211
• UDI-Public: (01)00868260000211
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/16/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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