MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE; Ventricular (assist) bypass

Model Number	106525US
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a driveline power fault alarm was confirmed via analysis of the returned modular cable.The returned modular cable (lot number: 10337246) was connected to a test system controller and a mock circulatory loop, and while manipulating the cable by hand a driveline power fault alarm activated.The wires in the modular cable were then electrically tested, and the cable did not pass testing, indicating an issue with the underlying wires.The outer jacket and underlying protective layers were then removed from the modular cable, and inspection of the wires revealed that the brown (power a) wire was broken.Damage to this wire would result in the reported event.Log files were submitted and downloaded for review and data from the event date of 26dec2025 was reviewed.The log files captured a driveline power fault alarm on (b)(6) 2025 from 15:55:59 to 18:40:46 that was associated with a pwr_a_broken fault; this is consistent with the damage to the brown wire identified during testing.No other notable alarms were observed in the log files.The alarms did not affect the controller¿s ability to operate the pump at the set speed.The reported event was determined to be due to a break in the power a wire in the modular cable.Although not conclusively determined, repetitive flexing of the modular cable during use over time may have been contributed to the observed underlying wire damage.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 ifu section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (auditory and visual), including driveline power fault alarms and the actions to take if the issue does not resolve.These sections also contain a subsection entitled "what not to do: driveline and cables", which explicitly cautions the user not to twist, kink, or sharply bend the driveline.Heartmate 3 patient handbook section 4 ¿ ¿living with the heartmate 3¿ explains how to properly care for the driveline and states, ¿keep your driveline clean.Wipe off any dirt or grime.If the driveline gets dirty, use a towel with mild dish soap and warm water to gently clean it.Never submerge the driveline or other system components in water or liquid¿.Heartmate 3 patient handbook section 10 ¿ ¿safety checklists¿ provides checklists to assist the patient in performing routine maintenance of heartmate 3 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 patient handbook and the instructions for use caution 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.The device history records were reviewed and the records revealed that the heartmate 3 modular cable, lot number 10337246, was manufactured in accordance with manufacturing and qa specifications.The modular cable was shipped to the customer on 10jul2024.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient experienced a driveline power fault alarm.Log files were submitted for review and captured driveline power fault a alarms on (b)(6) 2025.

• Brand Name: THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
• Common Device Name: 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24455756
• Report Number: 2916596-2026-01214
• Device Sequence Number: 9310371
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: (01)00813024013181(10)10337246(17)270515
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 106525US
• Device Catalogue Number: 106525US
• Device Lot Number: 10337246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/26/2026
• Date Device Manufactured: 05/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White