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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106531US
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2021
Event Type  malfunction  
Manufacturer Narrative
Patient gender was requested, but not provided. No further information was provided. A supplemental report will be submitted once the manufacturer's investigation is complete.
 
Event Description
It was reported that the patient came to clinic on (b)(6) 2021 with visible damage and exposed wires on their white power cable, as well as notable kinks on their modular cable. The site exchanged both the modular cable and controller without issue. There were no alarms associated with this event.
 
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Brand NameHEARTMATE 3 SYSTEM CONTROLLER
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key13191890
MDR Text Key286757786
Report Number2916596-2021-07605
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013235
UDI-Public00813024013235
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/05/2022
Device Model Number106531US
Device Catalogue Number106531US
Device Lot Number6890839
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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