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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK; VENTRICULAR (ASSISST) BYPASS
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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 2060
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2022
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 patient shoulder pack was damaged, was threadbare with several torn areas and had a broken zipper.It was also noted that there was a possibility that a battery or controller could fall out of it¿s intended location.The shoulder pack was discarded and replaced.No patient complications have been reported as a result of this event.
 
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 patient shoulder pack was damaged, was threadbare with several torn areas and had a broken zipper.It was also noted that there was a possibility that a battery or controller could fall out of it¿s intended location.The shoulder pack was discarded and replaced.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 shoulder pack was not returned for evaluation.Visual evidence provided by the site revealed that the pack had torn seams on the bottom of the pack.As a result, the reported "several torn areas" event was confirmed; however, the reported "broken zipper" event could not be confirmed due to insufficient evidence.Possible causes of the reported event may be attributed, but not limited to wear and/or due to the handling of the pack.Capa pr00519581 was created to investigate damaged packs.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.
 
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Brand Name
HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK
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 Key13549238
MDR Text Key285748670
Report Number3007042319-2022-02555
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707000055
UDI-Public00888707000055
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/28/2022
Device Model Number2060
Device Catalogue Number2060
Device Lot Number1729286
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
1103 VAD
Patient Age56 YR
Patient SexMale
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