MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 VAD MODULAR CABLE; LVAD MODULAR CABLE

Model Number 106525

Device Problems Break (1069); Cut In Material (2454)

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

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device: 47 days.The patient remains ongoing with the lvad device.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) 2017.It was reported that driveline fault alarms occurred.The patient exchanged system controllers; however, alarms persisted.The modular cable had "massive" distress along the entire length.The patient¿s system controller and the patient¿s modular cable was replaced.No additional information was provided.

Manufacturer Narrative

The evaluation of the modular cable confirmed an issue that could have contributed to the reported driveline fault alarm, which was confirmed through the evaluation of the system controller log files the evaluation of the modular cable revealed kinking; however, the report of massive distress along the entire length of the cable could not be confirmed through this evaluation.The review of the log files submitted via (b)(4) revealed a driveline power fault revealed that the driveline was disconnected on (b)(6) 2017 at 12:14, and a controller internal fault alarm and overcurrent protection on line b activated approximately 15 seconds later.The driveline power fault alarm activated approximately 3 seconds later, and the pump did not start.The driveline was disconnected and reconnected, and the pump started with the driveline power fault alarm still active.The exchanged modular cable was originally returned and evaluated under (b)(4).Per this evaluation, examination of the outer polyurethane jacket revealed kinking with no areas of apparent damage.Examination of the controller connector revealed a scorch mark one of the pins.In addition, the evaluation of the returned system controllers revealed a scorch mark on pin 3 in each of the bulkhead connectors.These findings appear consistent with the driveline being incorrectly inserted into the system controller by 180 degrees.The modular cable was connected to a returned system controller (after the controller¿s fuses were replaced) and a test heartmate 3 with test equipment.The modular cable was connected and disconnected from the controller several times without issue.Manipulating the modular cable had no effect on pump function.The modular cable passed the test procedure and ran with the returned controller for an extended period without any notable alarms activating.The heartmate 3 lvad patient handbook cautions the patient to not twist, kink, or sharply bend the driveline.Twists, kinks, or sharp bends can cause damage to the wires inside, even if external damage is not visible.Damage to the driveline could cause the pump to stop.This document also addresses all alarm conditions, including driveline power fault alarms.Further, this handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.This document and the heartmate 3 lvad instructions for use (ifu) also contain information regarding how to care for the driveline.

Manufacturer Narrative

Section a4: additional information.

• Brand Name: HEARTMATE 3 VAD MODULAR CABLE
• Type of Device: LVAD MODULAR CABLE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7558333
• MDR Text Key: 109803841
• Report Number: 2916596-2018-02266
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 106525
• Device Catalogue Number: 106525
• Device Lot Number: 185322
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 90