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

Model Number CF40A74C

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive for the reported faulty graft.The definitive root cause for the reported faulty graft could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 12/2021).

Event Description

It was reported that some time post graft placement, granuloma formation was identified on the graft site.The current status of the patient is unknown.

• Brand Name: CARBOFLO VASCULAR GRAFT
• Type of Device: 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: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12889397
• MDR Text Key: 281392319
• Report Number: 2020394-2021-80822
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021015
• UDI-Public: (01)00801741021015
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF40A74C
• Device Catalogue Number: CF40A74C
• Device Lot Number: VTAZ0214
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention