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

Model Number 1103

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2017

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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

A report was received stating that during pump assembly, as the screw clamp of the bend relief was being tightened down the screw top broke off leaving the remainder of screw inside clamp on bend relief.No excessive force used with tightening of screw with hex driver.Accessories kit opened and new used only for bend relief for pump assembly.No further information provided at this time.

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.

Manufacturer Narrative

Product event summary: the strain relief screw from the pump implant kit (b)(4) was returned for evaluation.The reported event of broken screw was confirmed through visual inspection of the returned device, which revealed that the head of the screw was detached from the screw body, which remained in the strain relief clamp.An internal investigation was initiated to capture events involving the broken clamp screw events.Potential root causes of broken clamp screws can be attributed to assembly technique in the field and/or a non-torque limiting hex driver which could allow for excessive torque to be applied when tightening.Corrective actions for such events are being implemented currently through internal investigation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• 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: anne schilling ; 8200 coral sea street ne; mounds view, MN 55112-3105 ; 7635052036
• MDR Report Key: 6960007
• MDR Text Key: 90591653
• Report Number: 3007042319-2017-03772
• 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,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• 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?: Yes
• Date Device Manufactured: 06/30/2017
• 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: 123