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

Catalog Number HERO1001

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

Patient Problem Thrombus (2101)

Event Date 10/19/2016

Event Type  No Answer Provided  

Manufacturer Narrative

One device is expected to return for evaluation.A follow up will be submitted when evaluation is complete.

Event Description

The physician had a follow up appointment with the patient and the hero device was found to have clotted.The patient has had multiple thrombosed av fistulas in the past.The patient is refusing to have the interventional procedure at this time.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually and no defects could be identified.The complaint could not be confirmed and the root cause could not be determined.A review of the complaint database and device history record could not be performed since the lot number was not provided.

• Brand Name: HERO®.VENOUS OUTFLOW COMPONENT.
• Type of Device: HERO GRAFT
• 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: 6115129
• MDR Text Key: 60412070
• Report Number: 1721504-2016-00226
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening