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 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

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 - 2 years and 9 months.The patient remains ongoing on lvad support.The modular cable was returned for investigation.The evaluation is not yet complete.  the pump was not explanted; therefore, the pump is not available for evaluation.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) 2015.It was reported that the patient presented with cuts and tears on the distal end of the modular cable.The modular cable was replaced.

Manufacturer Narrative

The evaluation of the returned modular cable confirmed the report of discoloration and cosmetic damage to the outer jacket of the modular cable.Examination of the returned modular cable revealed discoloration of the polyurethane jacket.The polyurethane jacket was taped approximately 12 inches from the system controller connector and at the terminus of the inline connector bend relief.Removal of the tapes revealed that the jacket had become bunched up and torn at the terminus of the inline connector bend relief; however there appeared to no damage to the underlying layer.Both the system controller connector and inline connector bend reliefs showed gradient, dark yellow discoloration.The system controller and inline connector pins appeared unremarkable.The modular cable passed electrical testing without issue.The evaluation could not conclusively determine the cause of the outer jacket tear and discoloration.The ifu and patient handbook contain information in regards to caring for the driveline and instructs the user to check the driveline daily for signs of damage such as cuts, holes, or tears.The ifu instructs the user to clean exterior surfaces of the driveline cables with a damp, lint-free cloth and if more aggressive cleaning is needed, to use warm water and mild dish soap.A review of the device history records revealed that the device met applicable 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 95488
• MDR Report Key: 7556302
• MDR Text Key: 109632298
• Report Number: 2916596-2018-02259
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

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: 09/30/2015
• Device Catalogue Number: 106525
• Device Lot Number: 145746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 76