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

Catalog Number 1104

Device Problems Loose or Intermittent Connection (1371); Cut In Material (2454)

Patient Problem No Code Available (3191)

Event Date 09/29/2013

Event Type  malfunction  

Manufacturer Narrative

The hvad pump (hw1844) was not returned to manufacturer for analysis as it remains implanted in the patient.Review of the manufacturing documentation confirmed that pump (hw1844) met all requirements for release.The reported driveline wire damage event was confirmed via review of the controller log files and visually by the heartware field specialist who performed the servicing procedure.The root cause of the event is due to the user error from the patient damaging his driveline by inadvertently cutting through the blue wire while performing garden work with hedge trimmers.Based on review of the available information, there is no evidence to suggest that a device malfunction led 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.Ifu00064 revision 02 advises the patient do not pull, twist or kink the driveline or power cables, especially while sitting, getting out of bed, adjusting controller or power sources, or when using the shower bag.Patient manual dw200009 rev 09, provides warnings to the patient regarding driveline care.It instructs the following: do not disconnect the driveline from the controller or the pump will stop.If this happens, reconnect the driveline to the controller as soon as possible to restart the pump.Keep extra driveline length tucked under clothing or secured with an abdominal binder or dressing.Do not let any portion of driveline hang freely where it might get caught on external items such as doorknobs or the corners of furniture.Heartware is submitting this correction to a previously submitted mdr 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.(b)(4).

Event Description

The site reported that the patient was doing garden work and was cutting his hedge with a hedge trimmer.The hedge trimming tool accidentally came into contact with the driveline and cut into it.Immediately, the controller sounded an electrical fault alarm.Subsequently, the alarm sounded intermittently.The patient went to the clinic, where the vad coordinator inspected the damage and splinted the area to secure the driveline.A preliminary review of the log files showed an electrical fault on front phase b (blue wire) intermittently.The next day, a heartware field service engineer went to the site and investigated the damaged driveline.It was observed that the blue wire was damaged and that the insulation was broken.Due to the aforementioned splint, no further investigation was possible.After the operating room was prepared, the tape and splint were removed, and it became clear that the blue wire was completely cut through (near the driveline connector).The heartware field service engineer performed a driveline splice repair following mp00180 rev04 with additional use of the y-cable.Procedure went smoothly and there were no complications.Pump restarted as intended with the y-cable in dual stator mode.During the procedure, the pump was off twice, for about 10 seconds each time.All available and relevant information was provided at the time of the report; therefore, no attempts to obtain additional event information are required at this time.

• 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6081673
• MDR Text Key: 59347004
• Report Number: 3007042319-2016-03898
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2011
• 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; Required Intervention