MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 VAD MODULAR CABLE; VENTRICULAR (ASSISST) BYPASS

Model Number 106525

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: event date was estimated.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that an unknown modular cable exchange was performed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the returned modular cable confirmed cosmetic damage to the outer jacket of the cable.Examination of the returned modular cable revealed that the outer jacket had discoloration along the length of the cable.There were small abrasions and damage to the outer jacket approximately 6¿ to 8¿ from the controller connector; however, there were no areas of damage along the outer jacket that resulted in a full breach of the jacket.Further visual inspection of the outer jacket revealed areas where the surface was cracked with a spongy texture approximately 11¿ to 12¿ from the controller connector.Additionally, the inline connector and controller connector bend reliefs showed yellow discoloration.Upon disassembly of the cable, examination of the underlying layers revealed no evidence of damage.The 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 cosmetic jacket damage or discoloration.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) and patient handbook contain information in regards to caring for the driveline and instruct 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 VAD MODULAR CABLE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10999061
• MDR Text Key: 221299163
• Report Number: 2916596-2020-06076
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1