MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC HERO ARTERIAL GRAFT

Catalog Number HERO1002

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

Patient Problems Cardiopulmonary Arrest (1765); Patient Problem/Medical Problem (2688)

Event Date 06/02/2017

Event Type  Injury  

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 complaint database and device history record could not be performed since the lot number was not provided.

Event Description

The account reports that a patient coded upon completion of a hero graft replacement.The patient had a hero placed two years ago for fistula revision and a revision two weeks ago, but it clotted off.The physician chose to replace the entire graft portion.The new graft was placed successfully with good flow confirmed by doppler.Upon closing the skin and after anesthesia, the physician administered a propofol bolus at which time the patient's vitals became unstable.The patient's blood pressure and heart rate dropped and he went into arrest.Code blue was called and cpr was performed by hospital staff.The patient was stabilized on pressors, remained intubated and was transferred to icu.

• Brand Name: HERO ARTERIAL GRAFT
• Type of Device: ARTERIAL GRAFT
• 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: 6646416
• MDR Text Key: 77726194
• Report Number: 1721504-2017-00136
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2017

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: Health Professional
• Device Catalogue Number: HERO1002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/16/2017
• 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