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

Model Number	106525US
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	09/24/2025
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 during implant multiple attempts were required to advance the modular cable to lock on the driveline to cover the yellow line.
Event or Problem Description
It was reported that there was only difficulty on first attempt out of box and hat the patient did not suffer from any adverse events due to this.It was confirmed connection was successfully made after attempts.The patient was said to have undergone standard post operative care after the event.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event of difficulty connecting to the modular cable was not confirmed.The modular cable was not returned for further analysis, and no log files were submitted for review.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed, and the records revealed the heartmate 3 vad modular cable (lot number: 10976108) was manufactured in accordance with manufacturing and qa specifications.The current revision of the instructions for use (ifu) can be found on the electronic ifu page of the abbott website.Heartmate 3 instructions for use (rev.D) section 2 ¿ ¿system operations¿ instructs the user on how to correctly insert the driveline into the system controller, stating ¿insert the driveline cable connector into the socket, pressing firmly until it snaps into place.Move the safety lock to the locked position, so that it covers the red button.¿ additionally, the heartmate 3 patient handbook (rev.A) section 2 ¿ ¿how your heart pump works¿ warns the user to ¿check the system controller driveline connector often to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump will stop.¿ the document states that if the driveline disconnects from the system controller, promptly reconnect it to resume pump operation.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.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23318203
• Report Number: 2916596-2025-06712
• Device Sequence Number: 4838549
• Product Code: DSQ
• UDI-Device Identifier: 05415067039385
• UDI-Public: (01)05415067039385(10)10976108(17)280801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 11/10/2025

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: Health Professional
• Device Model Number: 106525US
• Device Catalogue Number: 106525US
• Device Lot Number: 10976108
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 10/31/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/31/2025; 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White