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

Model Number AG750

Device Problem Hole In Material (1293)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

As reported by an independent sales representative, while a doctor was performing a femoropopliteal bypass (fem pop) procedure, he noticed a hole on the wall of an artegraft collagen vascular graft.The doctor sutured the hole in the graft and completed the procedure.The patient status is stable; no adverse events were reported.Although requested by artegraft, the reporter and doctors office did not provide any additional data.

Manufacturer Narrative

(b)(4).Method: the artegraft was implanted and not returned for evaluation.The device batch record was reviewed.Results: no evaluation was performed with the actual graft as the device was implanted and not returned.Review of the batch record did not identify and anomalies or non-conformances.Capa (b)(4) was previously created to investigate a similar issue; the investigation is currently ongoing.Conclusion: although the actual device was not returned and the complaint was not able to be confirmed, there is an ongoing capa investigation for this type of issue.Capa investigation and results will be maintained at artegraft.The complaint and type of malfunction will be added to artegraft's quality data trending program.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902 ; 7324228333
• MDR Report Key: 4138225
• MDR Text Key: 4912712
• Report Number: 2247686-2014-00004
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: AG750
• Device Catalogue Number: AG750
• Device Lot Number: 14G177-017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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