MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. WAVELINQ 4FR; ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE

Model Number	W04200
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date (04/2021).
Event or Problem Description
It was reported that during an attempt to create a ulnar artery - ulnar vein arteriovenous fistula, both catheters were advanced into the ulnar vein and artery, after the catheters were aligned perfectly, the venous catheter allegedly failed to cut the tissue.A surgical fistula will be scheduled for a future date.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record and manufacturing review was not required as this is the first complaint for this lot number.Investigation summary: a sample evaluation was performed.Electrode height measurement was taken and found to be approximately 1.335mm.A porcine tissue cutting test was performed on carotid artery tissue measuring 0.98mm.Tissue cut was successful and measured and found to be approximately 3.97mm.The investigation is unconfirmed for failure to cut due to the results of functional testing.The definitive root cause could not be determined based upon available information.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.H10: g4, d4 expiry date (04/2021).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 an attempt to create a ulnar artery - ulnar vein arteriovenous fistula, both catheters were advanced into the ulnar vein and artery, after the catheters were aligned perfectly, the venous catheter allegedly failed to cut the tissue.A surgical fistula will be scheduled for a future date.There was no reported patient injury.

• Brand Name: WAVELINQ 4FR
• Common Device Name: ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10389430
• Report Number: 3011392541-2020-00008
• Device Sequence Number: 3446624
• Product Code: PQK
• UDI-Device Identifier: 00801741182754
• UDI-Public: (01)00801741182754
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K182796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: W04200
• Device Catalogue Number: W04200
• Device Lot Number: S0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1