MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION GRAFTS ADVANTA VXT W/GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 22059

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During an avf (left upper arm) procedure the gds was separated during the process of graft removal by connecting the avf (left upper arm) tunneler.Return of problematic products is not possible as they are inserted into the patient's body.Current patient status - nothing special.

• Brand Name: GRAFTS ADVANTA VXT W/GDS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 18883009
• MDR Text Key: 337663812
• Report Number: 3011175548-2024-00077
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862220599
• UDI-Public: 00650862220599
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K992960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22059
• Device Catalogue Number: 22059
• Device Lot Number: 501930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Date Device Manufactured: 10/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TUNNELER 6MM, KELLY (SURGICAL INSTRUMENT)
• Patient Sex: Prefer Not To Disclose