MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC HERO®.ARTERIAL GRAFT COMPONENT; HERO® GRAFT COMPONENT

Catalog Number HERO1002

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the device history and complaint data base could not be reviewed since the lot number was not provided.

Event Description

Physician was performing a de-clotting procedure with a fogarty balloon and discovered a void located at the connector caused by an unknown source.The fogarty balloon exited the graft right at the connector during the procedure.The separation of the graft and connector had allowed tissue ingrowth.The original device had been in place for approximately 2 years.The patient did undergo a previous de-clot procedure in the past.The old outflow component was replaced restoring the outflow.

• Brand Name: HERO®.ARTERIAL GRAFT COMPONENT
• Type of Device: HERO® GRAFT COMPONENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes ms, cqe ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6155106
• MDR Text Key: 61865301
• Report Number: 1721504-2016-00229
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: HERO1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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