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

Model Number AG740

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

An artegraft distributor was contacted by an end-user hosp requesting the return of an artegraft ag740, control # (b)(4).The end-user reported that he noticed a hole on the side of the graft during preparation.The ned-user also felt that the graft was 'harder' than usual.An alternate graft was used during the surgery.The end-user reported that there was no patient involvement, and the patient had a successful surgery.

Manufacturer Narrative

The graft was returned to artegraft for further eval on (b)(4) 2014.The graft was evaluated and tested to identify the presence of any holes/wall defects and to observe the graft for an unusual feeling.The returned artegraft ag740 control #(b)(4) was opened and tested on (b)(6) 2014.The graft was pressurized under water using a syringe.A wall defect was visually noticed at that time.On june 10 2014 the returned artegraft ag740 control #(b)(4) was tested by a qualified artegraft mfg tech following the pressure test requirements in the artegraft processing specification, ps001.The wall defect was noticed during this test.The mfg tech determined that the defect was due to a small, unligated tributary that had been flattened and affixed to the outside wall of the graft.During the tanning chemical process, the small, flattened tributary became temporarily sealed to the side of the graft wall and passed initial pressure testing.The defect was also not detected during the visual inspection prior to final release.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center dr.; north brunswick NJ 08902
• Manufacturer Contact: cynthia salter ; 206 north center dr.; north brunswick, NJ 08902 ; 7324228333
• MDR Report Key: 4001667
• MDR Text Key: 19925854
• Report Number: 2247686-2014-00002
• 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: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Model Number: AG740
• Device Catalogue Number: AG740
• Device Lot Number: 14A024-023
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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