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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1103
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2022
Event Type  malfunction  
Event Description
It was reported that the ventricular assist device (vad) driveline cable had an abnormal appearance on a routine x-ray and it was suspected that there was an issue with a previous splice repair. No alarms were reported to have occurred and there was no evident damage present. The site was advised that the different driveline appearance was normal after a splice repair, as coiling can occur inside the splice tube due to the length of cable during splice and recoil of the original driveline during the splice cause a change in length of the cables. The driveline remains in use. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Concomitant medical products: 693565 lead and 55945 lead, implanted (b)(6) 2009. 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.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE
Type of DeviceVENTRICULAR (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 Key13307345
MDR Text Key284119948
Report Number3007042319-2022-00225
Device Sequence Number1
Product Code DSQ
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 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/20/2022 Patient Sequence Number: 1
Treatment
DDMC3D1 ICD
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