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

Model Number AG730

Device Problem Leak/Splash (1354)

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

Event Date 06/07/2015

Event Type  malfunction  

Event Description

As reported from an artegraft distributor, per the pre-implant instructions for use, the collagen vascular graft (artegraft) was clamped on one end, filled with hep-saline, and pressurized.A leak in the side vessel tributary was noticed at this time.The surgeon attempted to suture the graft from where the leak occured, but was unsuccessful and the graft was not implanted.The surgeon believes it was a side vessel tributary where the ligation may have failed.A second collagen vascular graft (artegraft) was available and was implanted without issues.It was reported that no patient adverse events were related to this event.

Manufacturer Narrative

The issue was identified during the pre-implantation evaluation prior to the product use.Batch record review was performed.No related ncmr/capa were identified.The batch record indicates that in process pressure testing and final qc inspection of the product met specifications.The returned graft was evaluated and the complaint issue was verified.Capa (b)(4) as previously initiated for further investigation.Conclusions are not yet available; pending completion, the results will be kept on file.The complaint issue will be monitored within artegraft, inc.Quality systems quality assurance trending.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902
• Manufacturer (Section G): ARTEGRAFT, INC; 206 north center drive; north brunswick NJ 08902
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902 ; 7324228333
• MDR Report Key: 4874173
• MDR Text Key: 6259561
• Report Number: 2247686-2015-00004
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: AG730
• Device Catalogue Number: AG730
• Device Lot Number: 14H206-013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2014
• 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