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

Model Number	AG740
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902 4247
• MDR Report Key: 5563551
• Report Number: 2247686-2016-00003
• Device Sequence Number: 10861372
• Product Code: LXA
• UDI-Device Identifier: 00316837000299
• UDI-Public: (01)00316837000299(17)180731(10)15F167-014
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2016
• Initial Report FDA Received Date: 04/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1