MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1403US

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/20/2017

Event Type  malfunction  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller had a loose power port.The controller was exchanged.The patient is a participant in the ventricular assist device (vad) lateral study clinical trial.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the returned controller passed functional testing and failed visual inspection.The reported complaint was confirmed.Investigation is ongoing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7116207
• MDR Text Key: 95376843
• Report Number: 3007042319-2017-04895
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000116
• UDI-Public: 00888707000116
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2016
• Device Model Number: 1403US
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 90