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

Model Number 1103

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

The broken strain relief screw and the hex driver were not returned for evaluation.Review of the manufacturing documentation confirmed that the associated devices met all requirements for release.Visual evidence provided by the site revealed a broken screw head; thus confirming the reported event.Heartware had initiated an investigation to evaluate broken strain relief screws.Based on the investigation, the most likely root cause can be attributed to excessive torque applied to the component during installation.Per the instructions for use (ifu): the instructions for use (ifu) states to loosen the graft clamp screw and place the graft clamp over the lip of the hvad® pump outflow conduit.Verify that the clamp screw is on the outflow conduit and attached to the graft clamp.Tighten the clamp screw slightly with the hex driver, then rotate the strain relief so that clamp screw is located on the inner side of the outflow conduit.Finish tightening the clamp screw until resistance is met.Always rotate the strain relief so that the clamp screw is located on the inner side of the outflow conduit to avoid tissue irritation or damage.Do not use excessive force when tightening the clamp screw because this could damage the graft clamp or graft clamp screw and a loose connection may result in bleeding and/or an air embolus.Replace components if required.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 during the pump implant set-up in the operating room (or), the perfusionist was tightening the strain relief screw to secure the outflow graft/strain relief to the left ventricular assist device (lvad) pump.While tightening the screw, the head of the screw head suddenly broke off and remained attached to the original strain relief screwdriver.Multiple attempts to remove the screw head from the hex driver were unsuccessful.An implant accessories kit and surgical tools kit were opened to replace the strain relief and to access a new strain relief screwdriver.The event occurred while the patient was on the operating room table sedated and intubated.No patient complications have been reported as a result of this event.Photos of the reported event have been made available.No further information has been provided.

Manufacturer Narrative

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

Manufacturer Narrative

Supplemental mdr report is being submitted to include the associated fda z-number issued for the reported issue captured in this report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - STRAIN RELIEF
• 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: 6915878
• MDR Text Key: 88255844
• Report Number: 3007042319-2017-03552
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2055-2020
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 53