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

Model Number AG 636

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2013

Event Type  malfunction  

Manufacturer Narrative

Data trending indicates that there was no complaint rec'd in 2013 of a graft from a different lot where leakage was noticed during surgery.The graft in question was returned to artegraft for physical eval.The conclusion of the explanted graft investigation will be included in artegraft complaint file (b)(4) along with the fmea and specific health hazard analysis documentation.

Event Description

An artegraft distributor was contacted by an end-user hospital requesting credit for an artegraft ag 636, control #(b)(4).The graft was described as having noticeable leaks during the implant surgery.The graft was removed and another graft was used to complete the surgery.As reported by mr.(b)(6), the pt was doing well as a result of the replacement surgery.A review of the device history record was completed immediately after the report was rec'd, and graft #13b044-023 had passed all required testing at the time of release.Size: 6mm od, 36 cm length.

• Brand Name: ARTEGRAFT COLLAGEN VASCULAR GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; north brunswick NJ 08902
• Manufacturer Contact: cynthia salter ; 206 north center dr.; north brunswick, NJ 08902 ; 7324228333
• MDR Report Key: 3703509
• MDR Text Key: 18564368
• Report Number: 2247686-2014-00001
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: AG 636
• Device Catalogue Number: AG 636
• Device Lot Number: 13B044-023
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/26/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2013
• 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
• Patient Outcome(s): Required Intervention