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

Model Number	106525
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that patient arrived to clinic on (b)(6) 2024 with noted telescoping to modular cable and damage to driveline.Rescue tape was applied to driveline.It was attempted to connect the new modular cable to the secondary system controller without success of insertion of connector into the controller.The controller was also replaced along with modular cable.It was indicated that the patient experienced an adverse event that required intervention to prevent permanent impairment/damage.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the modular cable (lot number: unknown) being unable to be inserted into the backup system controller could not be confirmed, as the product was not returned for analysis.Available information indicated that the modular cable was exchanged.It was noted on the medwatch form that the patient experienced an adverse event that required intervention, but the type of adverse event was not specified.Multiple attempts were made to obtain additional details related to the event, but no response was received.The root cause of the reported event could not be conclusively determined through this analysis.The current revision of the instructions for use (ifu) (rev.D) and patient handbook (rev.A) can be found on the eifu page of the abbott website.Section 2 of the ifu, ¿system operations,¿ contains instructions regarding how to disconnect the drivelines from the system controller.This section instructs the user to orient the system controller, so the display is facing down, rotate the safety lock to the unlocked position, and firmly press the red button under the safety lock, while pulling the system controller driveline connector from the socket.The section further instructs the user to grasp the bend relief of the modular cable while removing it and to not pull on or bend the system controller driveline connector.Section 4 of the ifu and patient handbook, ¿living with the heartmate 3¿, contains information regarding how to clean and care for the driveline.This section instructs the user to check the driveline daily for signs of damage and to call your hospital contact right away if the driveline is damaged.Furthermore, the patient handbook instructs 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 relevant sections of the device history records for the modular cable were unable to be reviewed as the lot number was not provided.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: 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: 24254412
• Report Number: 2916596-2026-00554
• Device Sequence Number: 21237035
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: (01)00813024013181
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 106525
• Device Catalogue Number: 106525
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male
• Patient Weight: 63 KG