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

Model Number 1440

Device Problem Component Missing (2306)

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

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that the silver part at the tip of controller dc adapter was missing since it was unpacked.The controller dc adapter was removed from service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: the controller dc adapter was returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.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 a missing spring, fuse, center pin, and knurled threaded nut on the inlet connector.The missing components resulted in the adapter unable to provide power.During supplemental testing, the missing components from the inlet connector were replaced and then the device worked as intended.As a result, the reported event was confirmed.A possible root cause of the reported event can be attributed, but not limited to improper assembly.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.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 DC ADAPTER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10869278
• MDR Text Key: 217165246
• Report Number: 3007042319-2020-07381
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2018
• Device Model Number: 1440
• Device Catalogue Number: 1440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1104JP VAD.; 1104JP VAD
• Patient Age: 53 YR