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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
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Product event summary: a pump with unknown serial number was not returned for evaluation. Review of the manufacturing documentation could not be performed since the device serial number was unknown. Review of the controller log files was not performed since log files covering the reported event date were not available for analysis. The reported event could not be confirmed due to insufficient evidence. A splice repair was performed to mitigate the reported event. Based on the available information, the reported event may be attributed to improper handling. This event was reported in the q3 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was admitted after completely severing the ventricular assist device (vad) driveline. The patient was reportedly using an automobile automatic buffer and when he moved the buffer in a downward motion against the car, it caught his driveline and cut it completely in half. An engineer was able to splice a new driveline and the patient was fairly asymptomatic. During the time that the patient was in the emergency room and the pump was off, the patient was given heparin and milrinone. These medications were stopped after the driveline was repaired and the pump was turned back on. The patient was monitored overnight. The vad remains in use. No further patient complications were reported as part of the event. This event was reported in the q3 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.
 
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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 Key13467117
MDR Text Key288795487
Report Number3007042319-2022-02276
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 Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/05/2022 Patient Sequence Number: 1
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