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

Catalog Number 1103

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

Driveline was inspected during service and remains implanted.The controller evaluated during service, is not expected to be returned to manufacturer.Log analysis - for general information purposes- con099201 log file analysis review date: august 13, 2015.Data through: august 13, 2015.Normal power consumption.1 electrical fault alarm was logged on august 12, 2015.The heartware vad is used for treatment not diagnosis.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 (ifu) outlines required surgical steps to prevent driveline contamination during tunneling.It additionally warns that failure to follow instructions on protecting the driveline connector or improper use of the driveline cap could result in contamination or damage to the connector and electrical fault alarms could occur.The ifu and patient manual also include a reference guide for alarms including potential causes and actions to take.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This is one of two reports (3007042319-2015-02225 and 3007042319-2015-02226) submitted for devices related to the same event.

Event Description

It was reported that a patient experienced an electrical fault alarm while at home.The patient lives in an area far from an implanting facility and had to be flown to a facility for driveline sheath repair.From service report: driveline inspection showed deep cut in driveline outer sheath and partial cut in the inner lumen.Electrical faults couldn't be reproduced.Driveline sheath repair was performed.This action is noted to have resolved the issue.There are no reported consequences or impact to the patient.No additional information provided.

Manufacturer Narrative

The driveline cable was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event was confirmed via review of the controller log files, which revealed 1 electrical fault.The electrical fault alarm may be indicative of compromised inner lumen wires, or an overcurrent condition due to an electrical short in the driveline or driveline connector as a result of the damage sustained to the driveline.Furthermore, on-site inspection of the driveline cable revealed a deep cut through the outer sheath and partial cut in the inner lumen which aligns with the log file analysis.The confirmed malfunction is related to the reported event.The most likely root cause of the reported electrical fault alarm can be attributed to a severed driveline.The most likely root cause of the driveline sheath damage is exposure to uv light.Heartware has opened an internal investigation to evaluate this type of issue.The most likely root cause of the reported electrical fault alarm can be attributed to a severed driveline.The most likely root cause of the driveline sheath damage is exposure to uv light.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This is one of two reports (3007042319-2015-02225 and 3007042319-2015-02226) submitted for devices related to the same event.

• 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: 5082234
• MDR Text Key: 26012277
• Report Number: 3007042319-2015-02225
• 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
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• 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