MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE VASCULAR GRAFTS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

An inquiry was made by the nephrologist inquiring about the access technique to cannulate the flixene vascular grafts in patients that experience pain.

Manufacturer Narrative

There was no device returned and no product part number or lot number provided therefore a device history record review could not be performed.An inquiry was made by an nephrologist about the use of the buttonhole technique to cannulate the flixene vascular grafts.The button hole technique is a way to cannulate a graft using a dull needle placed into the exact same hole in the fistula every dialysis treatment instead of a sharp pointed needle every time.The instructions for use and within the flixene av access graft cannulation education pocket guide state: (be sure to rotate cannulation sites.Avoid sticking the graft in the same location twice to reduce the risk of graft damage and possible pseudoaneurysm formation).It is an expectation that the insertion of a needle into the body will result some level of pain.Individual physician practice determines how that pain will be treated or prevented.Atrium does not dictate physician practice, but provides instructions for use of the device.Based on the review of the product complaint details atrium medical corporation cannot confirm nor conclude that the manufacture or design of the product is at fault.There is ample information in the literature indicating that cannulating in the same location with the flixene grafts is not recommended.

• Brand Name: FLIXENE VASCULAR GRAFTS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10170152
• MDR Text Key: 195718144
• Report Number: 3011175548-2020-00827
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention