MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM

Catalog Number 1103

Device Problems Detachment Of Device Component (1104); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

Approximately one year and one month post heartware lvad implantation, it was reported that the patient presented to the hospital after observing a malfunction with the driveline connector.A heartware® field engineer performed a visual inspection which revealed residue on the articulating surfaces of the connector body.The field engineer cleaned the driveline connector which resulted in the connector functioning as expected.There was no reported patient injury as a result of this event.Investigation is ongoing.

Manufacturer Narrative

The product remains implanted in the patient, therefore, it will not be returned.Additional information will be submitted within thirty (30) days of receipt.Device remains implanted.

Manufacturer Narrative

The hvad is used for treatment not diagnosis.It was reported that the patient's driveline would not "click" into the controller and that the driveline connector had no movement.There was no reported patient injury as a result of this event.The hvad driveline cable was not returned because it remains implanted.Visual inspection by the manufacturer representative revealed that the locking mechanism and connector were working as intended.Additionally, debris was evident on articulating surfaces and back-nut of the connector body which was subsequently cleaned.The most likely root cause of 'driveline connector damage' could not be conclusively determined as the device functioned per specification, however it is possible that the debris found on the connector body and/or user error/perception may have contributed to the reported event.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings, including transportation.The instructions for use and patient manual outline the steps for handling and properly connecting power sources, including ensuring proper alignment, as well as instructions not to twist or force connections together in order to prevent damages.It is outlined to inspect the power connections and pins once a week, one at a time when changing the power source.Additionally there is a warning to keep spare, fully charged batteries and back up controller available at all time with a warning to switch to the back-up controller if there is a controller failure the steps for exchange of devices are also outlined.It further warns that damaged equipment should be reported to the manufacturer and inspected.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Heartware is submitting this report as a result of remediation activities related to fda warning letter fla-14-14, dated june 2, 2014, and pursuant to the provisions of 21 cfr part 803.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: tatyana chorny ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 4155705
• MDR Text Key: 4915809
• Report Number: 3007042319-2014-01022
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2013
• 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