MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CARBOFLO EPTFE VASCULAR GRAFT

Model Number	CFT4547C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will 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.(expiry date: 03/2023).
Event or Problem Description
It was reported that three years post-surgical graft implantation in avf, the hole was allegedly found on the graft.It was further reported that the blood was oozing from the area.It was further reported that the patient was taken to the operating room to repair the problem (graft oozing).The patient reported to be stable.

• Brand Name: CARBOFLO EPTFE VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14191766
• Report Number: 2020394-2022-00318
• Device Sequence Number: 4297981
• Product Code: DSY
• UDI-Device Identifier: 00801741020964
• UDI-Public: (01)00801741020964
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: CFT4547C
• Device Catalogue Number: CFT454-7C
• Device Lot Number: VTCQ0450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 77 KG