MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC HERO VENOUS OUTFLOW COMPONENT

Catalog Number HERO1001

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed and the root cause could not be determined.A search of the complaint database and device history record could not be performed since the lot number was not provided.

Event Description

A physician reported on (b)(6) that he had removed a hero venous outflow component that had migrated.The physician sutured the venous outflow component directly to a competitor's arterial graft without using the connector.The patient was experiencing problems during dialysis and went to the hospital for a follow up.An x-ray was ordered and revealed that the hero venous outflow component had indeed detached and had migrated into the patient's coronary sinus.The outflow component was retrieved from the patient with a snare device through the right femoral vein.A new outflow component was not placed.A temporary dialysis catheter was placed for patient dialysis.No further patient injury to report.

• Brand Name: HERO VENOUS OUTFLOW COMPONENT
• Type of Device: VENOUS OUTFLOW COMPONENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 west merit parkway; south jordan, UT 84095
• MDR Report Key: 6449400
• MDR Text Key: 71390540
• Report Number: 1721504-2017-00065
• 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: 03/16/2017

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: Physician
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention