MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 1.0; VENTRICULAR (ASSIST) BYPASS

Model Number 1403US

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/30/2018

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 controller had loose ports.The controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Visual inspection of the controller revealed that the serial port was missing the serial port data cap.In addition, visual inspection also revealed a loose power port one (1) and power port two (2) connector.As a result, the reported loose connector event was confirmed.Functional testing revealed power port one (1) was unable to accept power from a battery.Supplemental testing revealed that a wire was found disconnected from the connector, likely due to the loose power port.Functional testing also revealed that the "no power" alarm failed to sound when a power source was removed from power port tw o (2).Evaluation of the internal nickel-metal hydride (nimh) battery revealed that one of the cell's voltage level was below what was expected.The missing serial port data cap, the disconnected wire, and the faulty internal battery findings are not related to the reported event.The most likely root cause for the missing serial port cap can be attributed to handling of the device.The most likely root cause of the loose connectors can be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.The most likely root cause of the disconnected wire in the controller¿s connector can be attributed to the movement of the loose power port connector during normal use which caused stress on the wires.The most likely root cause for the ¿no power¿ alarm failing to sound can be attributed to a faulty internal nimh battery.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for corrections.Concomitant medical product corrected to mcs unknown vad.E1 initial reporter fax number corrected to 6163912840.E3 occupation corrected from health professional (hpro) to nurse (nurs).H6, h9, h10 as a result of review on the complaint file, this report contains an update to the product event summary to reference the formal investigation associated with the reported failure and associated z-number and also updates applicable fda results and/or conclusion code(s) to more accurately reflect what is in the complaint file.The previously reported failure and investigation findings remain unchanged.Product event summary: the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Visual inspection of the controller revealed that the serial port was missing the serial port data cap.In addition, visual inspection also revealed a loose power port one and power port two connector.As a result, the reported loose connector event was confirmed.Functional testing revealed power port one was unable to accept power from a battery.Supplemental testing revealed that a wire was found disconnected from the connector, likely due to the loose power port.Functional testing also revealed that the "no power" alarm failed to sound when a power source was removed from power port two.Evaluation of the internal nickel-metal hydride (nimh) battery revealed that one of the cell's voltage level was below what was expected.The missing serial port data cap, the disconnected wire, and the faulty internal battery findings are not related to the reported event.The most likely root cause for the missing serial port cap can be attributed to handling of the device.Based on an internal investigation, the most likely root cause of the loose connectors can be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.Based on an internal investigation, the most likely root cause of the disconnected wire in the controller¿s connector can be attributed to the movement of the loose power port connector during normal use which caused stress on the wires.The most likely root cause for the ¿no power¿ alarm failing to sound can be attributed to a faulty internal nimh battery.An internal investigation evaluated "no power" audible alarm failures.Of note, the controller was manufactured dec-2014.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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 1.0
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7469776
• MDR Text Key: 106876235
• Report Number: 3007042319-2018-01638
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000116
• UDI-Public: 00888707000116
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 1403US
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0005-2017; Z-1538-2017
• Patient Sequence Number: 1
• Treatment: MCS UNKNOWN VAD
• Patient Age: 69 YR
• Patient Weight: 78