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

Catalog Number 106525

Device Problem Cut In Material (2454)

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

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

The patient weight was not provided.The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6) long term trial.The gtin unique device identifier for the commercial heartmate3 modular cable is (b)(4).Approximate age of device - 2 year and 5 months.The patient remains on lvad support with no further issues reported.No further information was provided.A supplemental report will be submitted when the manufacturers investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2015.It was reported that the modular cable was cut when patient fell and system controller screen had white lines on it obstructing the view on some of the screen.There were no alarms for event.The patient was reported to be asymptomatic.The system controller and modular cable were exchanged.No further information was provided.

Manufacturer Narrative

The report of a cut in the outer jacket of the modular cable was confirmed.Examination of the returned modular cable noted that tape was wrapped around a portion of the cable adjacent to the driveline connector bend relief.The tape was removed and there were tears in the outer jacket.The polyurethane around the torn areas showed a cracked surface.The outer jacket material appeared to have expanded, causing the ends of the tears to push together and fold against each other.Visual inspection of the underlying armor layer found no evidence of damage.Examination of the modular cable connectors found no evidence of damage to the pins.The cable passed the manufacturing test procedure and was able to support a mock circulatory loop for an extended period of time without any issues while connected to the returned system controller.The evaluation could not conclusively determine the cause of the tears in the outer jacket.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 3 VAD MODULAR CABLE
• Type of Device: LVAD MODULAR CABLE
• 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 ; 7818528390
• MDR Report Key: 7084159
• MDR Text Key: 94934960
• Report Number: 2916596-2017-03057
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 106525
• Device Lot Number: 18936J
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• 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: 71 YR