MAUDE Adverse Event Report: HEMOSPHERE, INC. HERO GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number HERO 1001

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

According to a manuscript, the end stage of dialysis access: femoral graft or hero vascular access device, a patient developed bacteremia after hero graft implant.As bacteremia is a blood borne infection it is not know what component, if any, of the hero device contributed to the infection.This medwatch is for product code (b)(4).

Manufacturer Narrative

According to a manuscript, the end stage of dialysis access: femoral graft or hero vascular access device, a patient developed bacteremia after hero graft implant.As bactermia is a blood borne infection it is not know what component, if any, of the hero device contributed to the infection.This medwatch is for product code (b)(6).Product is terminally sterilized by a validated method and pcd's were found to be sterile post processing.The manufacturing records for lots, 0001742, 0001743, and 0001747 were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Without information about the timing and source of the infection, the relationship of the infection to the hero graft device in dr.Wong's patient cannot be determined.Infection is a known potential complication listed in the hero graft instructions for use (ifu).The hero graft ifu contraindicates use of the hero device in patients with known preexisting bacteremia.In addition, instructions for screening blood cultures to rule out asymptomatic bacteremia and recommended antibiotic therapy are also provided in the ifu.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4322264
• MDR Text Key: 17265668
• Report Number: 3006945290-2014-00104
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Device Lot Number: 0001747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2014
• 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): Other