MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; LVAD SYSTEM CONTROLLER

Catalog Number 106762

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Approximate age of device - 1 year, 9 months (calculated from the date when the system controller was issued to the patient).The device was returned for analysis.The evaluation is not complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2013.It was reported that a wire on the system controller¿s white power cable was exposed.Upon connecting the system controller to the power module, there was a surge and the power cable emitted out a ¿poof of smoke.¿ no alarms occurred and the patient was asymptomatic.The system controller was exchanged.No additional information was provided.

Manufacturer Narrative

The report of damage within the white power cable was confirmed through the evaluation of the returned system controller.The evaluation of the returned system controller revealed a burn mark on the outer jacket insulation of the white power cable where the strain relief of the white power connector was dissected.Movement of the white power cable, while the system controller connected to the power module, resulted in yellow wrench/yellow battery alarms on the power module.The white power cable became warm to touch and then burned when it was manipulated.The evaluation of the white power cable revealed compromised internal conductors underneath the grey outer jacket insulation.The insulation of the internal conductors appeared burnt, consistent to an electrical short between the internal conductors and the metal braided shield (ground).The evaluation of the returned system controller could not determine a specific mechanism that contributed to the white power cable damage.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: LVAD SYSTEM CONTROLLER
• 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 ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 6875121
• MDR Text Key: 87319468
• Report Number: 2916596-2017-02092
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 106762
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 141