MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. FLIXENE GW AND GWT GRAFTS > OR = 6MM; PROSTHESIS VASCULAR GRAFT

Model Number 25137

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 05/22/2014

Event Type  Injury  

Event Description

Patient received a graft for dialysis.Implantation of graft occurred without issue.Post implantation, the patient was experiencing a swollen arm with erythema in the u pattern of the graft which improved in a few days.

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: FLIXENE GW AND GWT GRAFTS > OR = 6MM
• Type of Device: PROSTHESIS VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 3931780
• MDR Text Key: 21875488
• Report Number: 1219977-2014-00191
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 25137
• Device Catalogue Number: 25137
• Device Lot Number: 200377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 76