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

Device Problem Physical Resistance (2578)

Patient Problem Sweating (2444)

Event Type  malfunction  

Manufacturer Narrative

A complaint investigation was not able to be performed as no product code, lot number, or sample was provided.Per the article in the case of the slider graft, ease of graft insertion was superior when compared to a standard ptfe graft.In addition, the slider graft demonstrated reduced tunnel and anastomotic bleeding.

Event Description

Received an article titled "better av grafts now: improved surgical techniques and graft conduits that all surgeons should know about." the article was to investigate a new system for tunneling in vascular access surgery.Per the article malfunction events included: graft sweating, resistance on insertion.

• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7341124
• MDR Text Key: 103151101
• Report Number: 3011175548-2018-00269
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• 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): Other