MAUDE Adverse Event Report: ARTEGRAFT, INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number AG740

Device Problem Device Handling Problem (3265)

Patient Problem Post Operative Wound Infection (2446)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Mw5082732.The report indicates that the artegraft product was not accessed following the artegraft, inc.Instructions for use (ifu).The ifu states that "a minimum of ten days should be allowed after implantation before puncturing the graft with needles for hemodialysis." the medwatch report states that the graft was accessed the day after the procedure.Patient information, lot /batch number, and details of the issue/event were not provided.No contact information and no hospital information were provided, therefore, artegraft, inc.Is not able to request follow-up information related to the event.A specific root cause was not able to be identified.

Event Description

Artegraft, inc.Received medwatch report mw5082732.The report states "accessed graft the day after my procedure and had severe bleeding and then developed an infection.Spoke with sensor sales person and said that it was acceptable to access next day and there is no evidence of previous infections".

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer (Section G): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 8345087
• MDR Text Key: 136327516
• Report Number: 2247686-2019-00001
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Model Number: AG740
• Device Catalogue Number: AG740
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention