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

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that the patient was admitted after tripping and dropping the controller, resulting in ventricular assist device (vad) driveline disconnection.The vad and controller remain in use.No further patient complications were reported as part of the event.This event was reported in the q2 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.

Manufacturer Narrative

A pump wth unknown serial number was not returned for evaluation.Review of the controller log files was not performed since log files covering the reported event date were not available for analysis.As a result, the reported driveline disconnection event could not be confirmed.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.The most likely root cause of the driveline disconnection event may be attributed to a physical disconnection of the driveline from the controller due to the reported controller drop, which was likely due to improper handling of the device.Additional products: brand name: heartware ventricular assist system ¿ driveline / model #: unk / catalog #: unk / expiration date: unk / serial or lot#: unk udi #: (b)(4) / device available for evaluation?: no.Mfg date: unk / labeled for single use?: yes / (b)(4).This event was reported in the q2 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 12661506
• MDR Text Key: 281515003
• Report Number: 3007042319-2021-07708
• 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
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/19/2021
• 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
• Treatment: UNK-VAD
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 68