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

Catalog Number 2060US

Device Problem Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

The shoulder pack was not returned for evaluation.A review of the manufacturing documentations could not be performed since the lot number of the shoulder pack was not provided.Applicable risk documentation and experience with events of similar circumstances were considered; events with damaged snap hooks are most often attributed to wear over time or due to the handling of the bag.The unit, however, was not available for analysis.Per the instructions for use (ifu): the patient shoulder pack is used to safely secure, store and carry the controller and batteries.It can be used in or out of the hospital, when resting, sleeping or ambulating.The instructions for use (ifu) and patient manual caution the user to use only manufacturer supplied components with their manufacturer system.Users are instructed that the shoulder pack can be washed by hand using a mild detergent and cold water, or machine washed using the delicate cycle.Users are instructed to not use bleach and to allow it to air dry.Users are further warned to not used a clothes dryer and to make sure that the pack is completely dry before use.In addition, they are guided to inspect it for damage or wear before each use.Lastly, users are instructed to return any damaged components to the manufacturer.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 Description

A report was received that the karabiner of the patient's shoulder pack broke causing the bag to drop down unexpectedly.The drop resulted in tension on the driveline cable when the peripheral devices fell.The patient reported feeling pain and irritation at the driveline exit site.The shoulder pack was subsequently exchanged with no further patient complications.Photo of the damaged shoulder pack was provided.

• 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6632258
• MDR Text Key: 77273428
• Report Number: 3007042319-2017-01768
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2060US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1