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

Catalog Number	1435
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cdc adapter was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event could not be confirmed through log file analysis since this event is related to the controller's dc adapter.Analysis of the device could not be performed since the device was not returned for evaluation.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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This event was assessed and is being reported as part of a retrospective review of events, which was in response to an update to the mdr decision criteria.
Event or Problem Description
It was reported that the patient was plugged into his controller dc adapter and did not realize the cable was short in length.The patient tried to walk further away than the cable would allow and broke the cable.The controller dc adapter was taken out of service, the patient is now very aware of the length of the cable.A new controller dc adapter, (b)(4)  was issued to the patient with no reported consequence or impact to the patient.No further information was provided.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6896087
• Report Number: 3007042319-2017-03390
• Device Sequence Number: 116934
• Product Code: DSQ
• UDI-Device Identifier: 00888707000109
• UDI-Public: 00888707000109
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2016

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 Catalogue Number: 1435
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 70