MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER; VENTRICULAR (ASSISST) BYPASS

Model Number	1425US
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2017
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 and destination therapy 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.
Event or Problem Description
It was reported that the controller ac adapter cable was frayed and had multiple tears on the outer insulation.The ac adapter was exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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 unit revealed that the device passed functional testing; the controller ac adapter was able to adequately provide power to a test controller.Visual inspection revealed that the output cable contained a tear on the outer sheath.As a result, the reported event was confirmed.The most likely root cause of the damaged controller ac adapter output cable can be attributed to a tear on the output cable, due to wear and/or due to the handling of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7209281
• Report Number: 3007042319-2018-00325
• Device Sequence Number: 19079390
• Product Code: DSQ
• UDI-Device Identifier: 00888707000093
• UDI-Public: 00888707000093
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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 Model Number: 1425US
• Device Catalogue Number: 1425US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 63