MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM-SEWING RING SCREW; VENTRICULAR (ASSISST) BYPASS

Model Number 1153

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/22/2018

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 sewing ring screw was missing.The ventricular assist device (vad) remains implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The sewing ring associated with the pump, along with its accessories, was not returned for evaluation.Review of the manufacturing documentation confirmed that the sewing ring and associated screw met all requirements for release.The reported event could not be confirmed since the components were not returned and no evidence or supporting data was provided.There is no evidence to suggest that a component malfunction caused or contributed to the reported event.An investigation was initiated to evaluate this issue.Based on the available information, a possible root cause of the reported event may be attributed, but not limited, to an assembly error and/or improper handling of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM-SEWING RING SCREW
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7598011
• MDR Text Key: 110959611
• Report Number: 3007042319-2018-02439
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 1153
• Device Catalogue Number: 1153
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 70