MAUDE Adverse Event Report: ARTEGRAFT INC ARTEGRAFT COLLAGEN VASCULAR GRAFT BOVINE CAROTID ARTERY GRAFT; TISSUE GRAFT OF 6MM AND GREATER

Model Number AG 730

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2019

Event Type  malfunction  

Event Description

Graft was different size from what was stated on the box and it was opened.Graft not used.

• Brand Name: ARTEGRAFT COLLAGEN VASCULAR GRAFT BOVINE CAROTID ARTERY GRAFT
• Type of Device: TISSUE GRAFT OF 6MM AND GREATER
• Manufacturer (Section D): ARTEGRAFT INC; 206 north center dr.; n brunswick NJ 08902
• MDR Report Key: 9254863
• MDR Text Key: 164276133
• Report Number: 9254863
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AG 730
• Device Catalogue Number: AG 730
• Device Lot Number: 17J269-029
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2019
• Date Report to Manufacturer: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA