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

Model Number	106525US
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that the patient had extensive driveline damage due to trauma from a dog chewing on it.The patient's international normalized ratio was subtherapeutic at the time of discovery and it was said the modular cable would be exchanged out later in the week.Log files were submitted for review and captured no evidence of any type of driveline electrical conductor issue in the log file.The log files contained pulsatility index events as well as routine power source changes.
Event or Problem Description
It was additionally reported that the modular cable was exchanged.The damage was confirmed to only be on the modular cable and not the pump cable.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported superficial damage to the modular cable could not be confirmed as no images were submitted for review and the product was not returned for evaluation.Although a specific cause for the superficial damage could not be conclusively determined through this evaluation, the account reported that a dog chewed on the driveline.Review of the submitted log files captured the system functioning as intended.The patient remains ongoing on heartmate 3 left ventricular assist system, serial number (b)(6).The relevant sections of the device history records for modular cable, lot number 10657373, were reviewed and showed no deviations from manufacturing or quality assurance specifications.The current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu, rev.D and the heartmate 3 patient handbook, rev.A are currently available.Section 2 of the ifu, ¿system operations¿, explains that if it has been determined that damage has been detected in the modular cable, it should be replaced, and provides instructions on how to do so.The ifu and patient handbook contain information on how to clean and care for the driveline.Section 6 of the ifu, ¿patient care and management¿, and section 4 of the patient handbook, ¿living with the heartmate 3¿, instruct the user to check the driveline daily for signs of damage, such as cuts, holes, or tears.The patient handbook also states, ¿call your hospital contact right away if the driveline is damaged (or might be damaged).¿ section 7 of the ifu, ¿alarms and troubleshooting¿, and section 5 of the patient handbook, ¿alarms and troubleshooting¿, provide additional instructions regarding driveline care in sub-sections entitled, ¿what not to do: driveline and cables¿.Furthermore, section 8 of the ifu, ¿equipment storage and care¿, and section 4 of the patient handbook instruct 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 soap.The patient handbook cautions the user to call their hospital contact 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: 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: 24191120
• Report Number: 2916596-2026-00604
• Device Sequence Number: 18604550
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: (01)00813024013181(10)10657373(17)280108
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 10657373
• Was Device Available for Evaluation?: No
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 138 KG