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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 12/29/2021
Event Type  malfunction  
Manufacturer Narrative
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 broke their controller pins in the white power cable when attempting to change power sources. The controller was exchanged.
 
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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 Key13290763
MDR Text Key285246580
Report Number2916596-2021-07860
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number106531US
Device Catalogue Number106531US
Device Lot Number8098070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2021
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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