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 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

Patient¿s weight was not provided.The heartmate 3 lvas was implanted during the momentum 3 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 momentum 3 long term trial.The gtin unique device identifier for the commercial heartmate3 modular cable is (b)(4).Approximate age of device ¿ 1 year and 7 months.The device was returned for investigation.The evaluation is not yet 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) 2016.It was reported that the patient¿s modular cable was exchanged.Reportedly there was a split in the modular cable and it was extremely dirty.The modular cable was exchanged without issue.

• 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: 7212370
• MDR Text Key: 98191106
• Report Number: 2916596-2018-00280
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• 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: 167931
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2016
• 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: 55 YR