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

Model Number 106525US

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported that the patient experienced driveline power fault alarms with no corresponding incident.Patient attempted to clear the fault but it returned immediately.The log files confirmed the reported driveline power fault for a possible broken a wire.Images showed some twisting of the patient's percutaneous lead.The patient never had their modular cable replaced.X-ray images showed some conductor bending/twisting near the patient's exit site.The modular cable was exchanged and the alarms resolved.The log files provided after the modular cable exchanged showed no additional driveline power faults.

Manufacturer Narrative

Modular cable serial number requested but not provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the log files that were provided by the account confirmed driveline power fault alarms; however, a specific cause could not conclusively be determined through this evaluation.The account submitted log files for review.The system controller event log files contain data from 03mar2022 at 10:19:52 through 15:55:05 when the driveline was disconnected and 13jun2022 at 16:11:52 through 14jun2022 at 16:11:52 post controller exchange.Additional events from additional controller contain data from 07jun2022 at 5:19:24 through 08jun2022 at 16:11:22 when the driveline was disconnected and 15jun2022 at 15:37:24 through 15:42:49 post controller exchange.Driveline power faults were captured throughout the entirety of the log file relating to a power a broken fault (f4).The pump appeared to function as intended.The heartmate 3 vad modular cable was not returned for analysis.Multiple attempts for additional information regarding product return were sent to the customer and no further detail was provided.The relevant sections of the device history records was reviewed and showed no deviations from manufacturing or qa specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 7, ¿alarms and troubleshooting¿, explains all alarms, including the driveline power fault alarm, and the actions associated to resolve the alarms.The driveline power fault alarm is an example of a non-transient alarm that requires specific user action to resolve the alarm condition and remains on the user interface screen until the alarm condition is resolved or permanently disabled, and therefore does not appear in alarm history.This ifu instructs users to ¿replace any equipment component that appears damaged or worn¿ in the ¿safety checklists¿ section.Also in this ifu, section 2 ¿system operations¿ and section 6 ¿patient care and management¿ explain that ¿damage to the electrical conductors within the driveline may or may not be preceeded by visible damage to the outer layer of the driveline.¿ signs of driveline damage can include a driveline power fault or driveline communication fault on the system controller.The heartmate 3 patient handbook also contains a section on ¿alarms and troubleshooting¿, which explains all alarms, including the driveline power fault alarm, and the actions associated to resolve the alarms.A section on "handling emergencies" is also included.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Controller referenced in mfr#2916596-2022-11799.

• 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: 14888037
• MDR Text Key: 303217687
• Report Number: 2916596-2022-11800
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: 813024013181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106525US
• Device Lot Number: 8140086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2021
• 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 Age: 37 YR
• Patient Sex: Male
• Patient Weight: 139 KG