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

Catalog Number 1104

Device Problem Cut In Material (2454)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/08/2014

Event Type  Injury  

Event Description

Approximately one week after hvad® implantation, it was reported that while having a dream, the patient cut his driveline using a swiss army knife, causing "electrical fault" alarms and damage to the outer sheath and inner lumen and wires at two locations.A preliminary review of the log files confirmed several "electrical fault" and "vad stopped" alarms on the reported event date.The heartware field service engineer performed a splice repair, after which the pump restarted without problems.The patient tolerated the procedure without any issues and it was reported to be in stable conditions following the repair.

Manufacturer Narrative

Additional information will be submitted within thirty (30) days of receipt.Device remains implanted.

Manufacturer Narrative

Hvad® pump was not returned to heartware for analysis as it remains implanted in the patient.Review of the manufacturing documentation confirmed that the pump met all requirements for release.Based on review of the available information,there is no evidence to suggest that a device malfunction led to the reported event.The damage was reported to have been patient induced.No additional information will be forthcoming.

Manufacturer Narrative

(b)(4) hospitalization.The hvad is used for treatment not diagnosis.It was reported that the patient cut part of the driveline cable using a swiss army knife after having a bad dream causing "electrical fault" alarms.The cuts caused damage to the outer sheath and inner lumen wires (blue and yellow) at two locations causing the pump to run on one stator.The damaged area is about fifteen (15) centimeters from the driveline exit site.A manufacturer's representative performed a splice repair per specifications, after which the pump started without problems.The patient felt fine during the procedure and tolerated the pump off time without any issues.The driveline cable was not returned to manufacturer as it remains implanted.Review of the log files confirmed the reported electrical fault alarms and pump running on single stator.Given the electrical fault alarms, vad stop alarms and vad disconnect alarms logged, this may be indicative of a compromised driveline inner lumen wires, or intermittent connection between the pump and the controller driveline port.The most probable root cause for the driveline wire damage is attributed to a user error as a result of induced cuts on the driveline cable.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 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: 4013127
• MDR Text Key: 4690079
• Report Number: 3007042319-2014-00855
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• 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