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

Catalog Number 1103

Device Problems Device Difficult to Setup or Prepare (1487); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2015

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 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.As per instructions for use (ifu) outlines proper surgical procedure in attaching sewing ring.A sewing ring attaches to the myocardium and allows for pump orientation adjustments intraoperative.It outlines to position the sewing ring to permit access to its screw after cannulation and ensure that the pump housing is flush with the sewing ring housing.It outlines to tighten sewing ring's screw around the pump inflow conduit using the wrench to tighten the screw until an audible "click" is heard.Based on the reported information, although no root cause conclusion can be made, it is possible that operational factors and positioning of the components may have contributed to the event.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Device not returned.

Event Description

It was reported that "o-ring was damaged during implant." "site not sure exactly what happened but when attempting to tighten the sewing ring it cut the o-ring".Surgical procedure was done by way of a "sternotomy." the pump was exchanged prior to turning it on with patient still on cardiopulmonary bypass.There was no report of any patient effect.No additional information provided.Investigation is ongoing.

Manufacturer Narrative

The o-ring was not returned to heartware for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event could not be confirmed since the device was not returned and there is no evidence or supporting data provided.However, heartware is aware of this issue and has initiated an internal investigation to evaluate these types of issues.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

• 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: 5050782
• MDR Text Key: 24902676
• Report Number: 3007042319-2015-02064
• Device Sequence Number: 1
• Product Code: DSQ
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1