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

Model Number	1440
Medical Device Problem Codes	Mechanical Problem (1384); Connection Problem (2900); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested regarding the specific location of where the loose component was of the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the controller dc adapter was not providing power to the controller and exhibited loose components after disconnection.The controller dc 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 evaluation.Product event summary: the controller dc 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.Failure analysis of the returned device revealed that the adapter passed external visual inspection and functional testing.Visual inspection did not reveal any anomalies on the inlet and output connectors.During functional testing, the adapter was able to properly connect and provide power to the test controller with no anomalies observed.Internal inspection did not reveal any faulty components; however, it was observed that a small piece of silicone, from the silicone between the printed circuit board and adapter housing, was loose inside the adapter.This did not affect the functionality of the device; all components were in place and functioned as intended.It is likely the observed loose piece of silicone was perceived as the reported "loose component".As a result, the reported "loose component" event was confirmed; however, the reported no power and poor mechanical connection event could not be confirmed.The most likely cause of the observed loose silicone within the adapter housing could be attributed, but not limited to handling of the device.A possible root cause of the reported "no power" event can be attributed, but not limited, to a marginal connection between the adapter and controller.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.
Additional Manufacturer Narrative
A supplemental report is being submitted for additional information.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.
Event or Problem Description
It was further reported that the controller dc adapter was loose at the connection where it plugs into the car.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER DC ADAPTER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 11619995
• Report Number: 3007042319-2021-03094
• Device Sequence Number: 14433195
• Product Code: DSQ
• UDI-Device Identifier: 00888707006842
• UDI-Public: 00888707006842
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/25/2021

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: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 1440
• Device Catalogue Number: 1440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 06/11/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/09/2021; 06/25/2021
• 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; 1103 VAD
• Patient Age: 47 YR