MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1420

Device Problem Moisture Damage (1405)

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

Event Date 09/05/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: brand name: heartware ventricular assist system ¿ unknown battery / model #: unk / catalog #: unk / expiration date: unk / serial #: udi #:(b)(4) / device available for evaluation: no / mfg date: unk / labeled for single use: no / (b)(4).Brand name: heartware ventricular assist system ¿ unknown battery / model #: unk / catalog #: unk / expiration date: unk / serial #: udi #: (b)(4) / device available for evaluation: no / mfg date: unk / labeled for single use: no / (b)(4).Additional information has been requested regarding the battery serial number and device disposition 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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's controller and the batteries were submerged in water.The controller and batteries remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for investigation complete.Product event summary: one (1) controller (b)(6), and two (2) batteries with unknown serial numbers were not returned for evaluation.Review of the available autologs report revealed that the pump parameters were within the normal operating range during the analyzed period.No alarms were logged within the analyzed period.The reported event could not be confirmed due to insufficient evidence.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the limited information available, the most likely root cause of the reported event can be attributed to handling of the devices, as described in the event details.Additional products: d1: heartware ventricular assist system ¿ unknown battery h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d1: heartware ventricular assist system ¿ unknown battery h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 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 2.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12468100
• MDR Text Key: 271293838
• Report Number: 3007042319-2021-06297
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000475
• UDI-Public: 00888707000475
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 1103 VAD; 1103 VAD
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 98 KG