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

Model Number	AG630
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the returned device ((b)(4)) was unable to confirm the complaint allegation of graft wall "leaking" and "thinner than usual" and the inner diameter of the graft met specifications for an ag630 product code.No additional complaints from this batch were reported to date.Batch record review was performed; the batch met all criteria, including pressure testing, sterility testing, and final visual inspection upon release.The patient status was reported as stable.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.
Event or Problem Description
Artegraft inc.Received an email communication from an authorized distributor (who was present with the doctor during the procedure) that an artegraft (collagen vascular graft) was identified as leaking during the pre-implant pressure testing per the corresponding artegraft ifu.Upon follow up communications, the distributor stated that no hole was visible but rather it appeared that the graft wall was "leaking and thinner than usual".It was also stated that when compared side by side, either the graft inner diameter may have been larger, or another graft's inner diameter was "much smaller" than the size on the label (5 mm id).This graft was not implanted.Another artegraft (ag630 product code) was utilized to complete the procedure.The patient is reported to be in stable condition.

• 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: 5517739
• Report Number: 2247686-2016-00001
• Device Sequence Number: 1096168
• Product Code: LXA
• UDI-Device Identifier: 00316837000220
• UDI-Public: (01)00316837000220(17)180331(10)15C064-007
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2016

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: 03/31/2018
• Device Model Number: AG630
• Device Catalogue Number: AG630
• Device Lot Number: 15C064-007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2016
• Initial Report FDA Received Date: 03/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR