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

Model Number 106525

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2022

Event Type  malfunction  

Event Description

It was reported that the patient experienced a driveline communication fault.The patient had already experienced this issue on (b)(6) 2022 and the issue had appeared to resolve after the controller was exchanged.The patient unsuccessfully attempted an controller exchange by themselves without contacting the site; the patient came to the site and the controller was successfully exchanged with help from a general practitioner.The modular cable was also exchanged.The alarms cleared following the exchanges.The patient was noted to be doing well clinically.Related controller mfr #: 2916596-2022-11391.

Manufacturer Narrative

The patient's previous driveline communication fault is reported under mfr #: 2916596-2022-11218.Manufacturer's investigation conclusion: the reported event of the patient experiencing a driveline communication fault was confirmed via analysis of the submitted log file; however, the reported event could not be reproduced during testing.The heartmate 3 vad modular cable was returned and evaluated at abbott.During the evaluation, the cable was observed and there was some corrosion buildup inside the inline connector next to the pins.The modular cable was functionally tested and passed all steps without issue.The modular cable was placed on a mock circulatory loop for an extended period of time and was able to support pump function without any atypical alarms or issues active.The cable was manipulated in an attempt to reproduce the reported event; however, the cable functioned as intended.The modular cable was then dissected to examine the underlying wires of the cable to reveal that the yellow (comm b) wire contained a slight cut in the insulation, exposing the underlying conductor.This could have caused a short, causing the controller to alarm for a driveline communication fault; however, the root cause is unknown due to the modular cable not being able to reproduce the reported event.Additionally, the submitted log file (labeled 125036) contained data spanning approximately 18 hours (b)(6) 2022 ¿ (b)(6) 2022).The log file captured a driveline communication fault due to a com a fault active on (b)(6) 2022 from 8:35:29 to 8:46:15.The alarm did not resolve on it own.The driveline was immediately disconnected in the next event and the controller was turned off.Pump speed was not affected by the alarm.The root cause of the reported event could not be conclusively determined through this analysis; however, the corrosion inside the inline connector or the exposed conductor in the underlying wire of the modular cable could have contributed to the event.Incidental findings: corrosion inside the inline connector next to the pins, kinked underlying wires with exposed conductor the device history records were reviewed and the records revealed the heartmate 3 vad modular cable (lot#: 7132509) was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate iii instructions for use (rev.G) section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook (rev.G) entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including driveline fault alarm conditions, and the actions to take if the alarms cannot be resolved.The heartmate iii patient handbook (rev.G) "living with the heartmate 3" (under "caring for the driveline") contains information regarding how to clean, care for the driveline, and connect it properly.This section instructs the user to inspect the modular cable in-line connector for signs of damage, such as cracking, fraying, wear, exposed wires, sharp bends, or kinks.Call your hospital contact right away if the driveline is damaged (or might be damaged)." the heartmate iii patient handbook (rev.G)¿safety checklists¿ provides checklists to assist the patient in performing routine maintenance of heartmate iii lvad, including inspecting the driveline cable for signs of damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.The heartmate iii patient handbook (rev.G) and the instructions for use (rev.G) cautions the user 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.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 (ASSIST) BYPASS
• 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 ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15131847
• MDR Text Key: 301099939
• Report Number: 2916596-2022-12611
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: 00813024013181
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2022
• Device Model Number: 106525
• Device Catalogue Number: 106525US
• Device Lot Number: 7132509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 90 KG