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

Catalog Number HERO1002

Device Problems Break (1069); Material Separation (1562)

Patient Problems Ischemia (1942); Renal Failure (2041)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.A follow up will be submitted when evaluation is complete.

Event Description

The titanium connector on the arterial graft connection came off when the physician was applying tension to the graft during insertion of the hero device.The surgeon was not able to reconnect the titanium connector to the arterial graft component so the surgeon was forced to suture the venous outflow component to the arterial graft component.The graft worked extremely well.The hero device had to be explanted because the patient developed steal syndrome.

Manufacturer Narrative

One used device was returned and visually inspected.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: HERO ARTERIAL GRAFT COMPONENT
• Type of Device: HERO ARTERIAL 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. ; merit medical systems inc; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6063471
• MDR Text Key: 58716895
• Report Number: 1721504-2016-00199
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: HERO1002
• Device Lot Number: H15AV011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• 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