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

Model Number AG740

Device Problem Leak/Splash (1354)

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

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

Batch record review of 15f167 was performed; the batch met all criteria, including pressure testing, sterility testing, and final visual inspection upon release.As the graft (b)(4) was not able to be returned for investigation, the complaint regarding the graft leak was not able to be confirmed.Capa-(b)(4) was previously initiated for further investigation.Conclusions are not yet available; pending completion, the results will be kept on file.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Should additional information become available, a follow-up report will be submitted.Graft remains implanted.

Event Description

Artegraft, inc.Received a phone call from an authorized distribution center regarding an incident of a leaking artegraft (collagen vascular graft).Upon follow-up discussions with the hospital's sales representative, it was stated that the leak (which appeared to be a tributary) was identified during the pre-implant pressure testing; a suture was used by the surgeon to seal the leak."the surgeon was confident after repairing the leak to proceed with implanting graft." no adverse events were reported and the status of the patient was reported as "all is ok".

• 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: 5563551
• MDR Text Key: 42195076
• Report Number: 2247686-2016-00003
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000299
• UDI-Public: (01)00316837000299(17)180731(10)15F167-014
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: AG740
• Device Catalogue Number: AG740
• Device Lot Number: 15F167-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2015
• 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