MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ADVANTA SST GRAFT

Model Number 22527

Device Problem Torn Material (3024)

Event Type  Injury  

Event Description

Received a report that the graft tore and could not be implanted.

Manufacturer Narrative

Upon sample receipt, and the receipt of the completed investigation, a follow up report will be submitted.

• Brand Name: ADVANTA SST GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, mgr ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3688047
• MDR Text Key: 4243131
• Report Number: 1219977-2014-00053
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K010516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 22527
• Device Catalogue Number: 22527
• Device Lot Number: AK08917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• 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