MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HERO ARTERIAL GRAFT COMPONENT..; PROSTHESIS, VASCULAR GRAFT,

Catalog Number HEROGRAFT

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

Patient Problem Unspecified Infection (1930)

Event Date 04/01/2024

Event Type  Injury  

Event Description

The customer reports a successful hero procedure was performed (b)(6) 2024.During a dialysis appointment the clinical staff noted a possible infection at the arterial anastomosis site.Positive culture for serratia bacteria was confirmed.The patient is scheduled for surgical consult to see if the device will need to be removed.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.

• Brand Name: HERO ARTERIAL GRAFT COMPONENT..
• Type of Device: PROSTHESIS, VASCULAR GRAFT,
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan, ut 84095 ; EI 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19088881
• MDR Text Key: 339930695
• Report Number: 1721504-2024-00022
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450563922
• UDI-Public: 884450563922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

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
• Device Catalogue Number: HEROGRAFT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention