MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. WAVELINQ ENDOAVF SYSTEM; ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE

Model Number	FX-001CE
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	07/15/2019
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 the arteriovenous fistula (avf) allegedly failed to create in the right arm, therefore, a surgical fistula was required to complete the procedure.The patient was stable at the conclusion of the procedure.
Additional Manufacturer Narrative
After further review of the details provided by the complainant, it was identified that the fda rn number and manufacturer (manufacturer name, city and state) was incorrect; the correct fda rn number is 3011392541 and the correct manufacturer (manufacturer name, city and state) is tva medical, inc.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.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 the arteriovenous fistula (avf) allegedly failed to create in the right arm, therefore, a surgical fistula was required to complete the procedure.The patient was stable at the conclusion of the procedure.

• Brand Name: WAVELINQ ENDOAVF SYSTEM
• Common Device Name: ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8876619
• Report Number: 2020394-2019-02399
• Device Sequence Number: 16791026
• Product Code: PQK
• UDI-Device Identifier: 00868260000211
• UDI-Public: (01)00868260000211
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/14/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1