MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER AC ADAPTER; CIRCULATORY ASSIST SYSTEM

Catalog Number	1425US
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device 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.The company is seeking this information through the event investigation.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
Event or Problem Description
It was reported by the ventricular assist device (vad) coordinator that the controller alternating current (cac) adapter had exposed wires.The cac adapter was removed from service and was replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
It was reported a controller ac adapter with exposed wires.The controller ac adapter was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned device revealed that the device failed visual inspection due to a tear on the output cable with exposed wires.This observation could possibly affect the functionality of the device.Based on the available information, the most likely root cause of the reported event can be attributed to a tear on the output cable due to the handling of the device. heartware will submit a supplemental report when new facts arise which materially alters information submitted in a previous mdr report.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER AC ADAPTER
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6820404
• Report Number: 3007042319-2017-02858
• Device Sequence Number: 11120388
• Product Code: DSQ
• UDI-Device Identifier: 00888707000093
• UDI-Public: 00888707000093
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/08/2015
• Device Catalogue Number: 1425US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 09/30/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 89