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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106015
Device Problem Mechanical Problem
Event Date 01/05/2020
Event Type  Injury  
Manufacturer Narrative

This event was also reported against the system controller in mfr. Report #2916596-2020-00350. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.

 
Event Description

It was reported that the patient was at a rehab facility and became disoriented and cut the drive line (dl) instead of the anchoring device for the dl. The controller was replaced with the backup controller following malfunction after patient damaged dl; controller was exchanged at the rehab facility because the controller stopped per the nurse at the rehab facility. The log file analysis showed continuous drive line fault events starting on (b)(6) 2020 after the clock was set on the controller. These drive line fault appeared to be authentic as it appears the patient may have nicked a wire when he cut the drive line. Unable to download log files on faulted controller, the controller will not activate when power applied.

 
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Brand NameHEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton , CA 94588
7818528204
MDR Report Key9656095
Report Number2916596-2020-00068
Device Sequence Number1
Product CodeDSQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
Device MODEL Number106015
Device Catalogue Number106015
Device LOT Number5804190
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/06/2017
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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