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

Model Number 2050

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Concomitant medical products: product id: 6935m62, product type: lead, implanted on: (b)(6) 2018; product id: dvfc3d4, implanted on: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the waist pack was torn.The waist pack 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 device evaluation.Product event summary: the waist pack 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 waist pack revealed torn seams around the controller pocket and one of the battery pockets.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed, but not limited to wear and/or to the handling of the pack.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 - WAIST PACK
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10945508
• MDR Text Key: 219506218
• Report Number: 3007042319-2020-07553
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000048
• UDI-Public: 00888707000048
• 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
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 2050
• Device Catalogue Number: 2050
• Device Lot Number: 1614141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1103 VAD; 1103 VAD
• Patient Age: 49 YR