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

Model Number	1430US
Medical Device Problem Codes	Fitting Problem (2183); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional 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.Concomitant medical products: dtba1q1 icd, implanted (b)(6) 2018; 5076-52 lead, implanted (b)(6) 2018; 459888 lead, implanted (b)(6) 2018; 6944-58 lead, implanted (b)(6) 2007.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the controller ac adapter had a stripped screw that was unable to be tightened on the bracket connecting the ac cord to the outlet.The bracket was removed to troubleshoot and the epoxy holding the screw washer in place split apart.The controller ac adapter was exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for device analysis and correction of result and conclusion evaluation codes.Product event summary: the controller ac adapter 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.The controller ac adapter was returned without a clamp assembly connector screw attached.Failure analysis of the controller ac adapter revealed the unit passed functional testing.Visual inspection and visual evidence provided by the site revealed that the clamp assembly was damaged.Visual evidence provided by the site has insufficient evidence for the reported stripped screw.The clamp connector screw returned with the clamp assembly had no visual anomalies.As a result, the reported damage event was confirmed.However, the reported "stripped screw" event could not be confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported "stripped screw" and damaged clamp assembly event can be attributed to handling of the device.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 AC ADAPTER
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9722415
• Report Number: 3007042319-2020-01423
• Device Sequence Number: 16232091
• Product Code: DSQ
• UDI-Device Identifier: 00888707002738
• UDI-Public: 00888707002738
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 1430US
• Device Catalogue Number: 1430US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD
• Patient Age: 73 YR