MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC HERO ARTERIAL GRAFT; CATHETER, INTRAVASCULAR, THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number HERO1003

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

Patient Problems Cardiac Arrest (1762); Perforation of Vessels (2135)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

Because the unit was not returned the root cause could not be determined.A review of the device history record and complaint database could not be performed since the lot number was not provided.If the device is returned in the future this investigation will be reopened and a follow up submitted.

Event Description

A doctor at the hospital mentioned to a merit sales representative that a surgeon had perforated the pericardium of a patient during a hero device implant, resulting in a code and open heart surgery.The doctor who had reported the case as well as another physician confirmed the failure was not due to the device.The patient needed surgery to repair svc perforation and is receiving dialysis at this time.The patient has since been discharged from the hospital.The surgeon who performed the procedure would not comment any further regarding details of the procedure.

• Brand Name: HERO ARTERIAL GRAFT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: jerry mcphie ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 5691302
• MDR Text Key: 46283473
• Report Number: 1721504-2016-00052
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HERO1003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention