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

Model Number	106525US
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a severe kink in the modular cable.The modular cable was exchanged.
Additional Manufacturer Narrative
Section a4: patient weight was not provided.Section d4: lot number was 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 complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a kink on the modular cable was unable to be confirmed.No log files were submitted for review.The heartmate 3 vad modular cable (lot number unknown) was not returned for analysis.Reported information stated that the modular cable was exchanged.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause for the reported event was unable to be conclusively determined through this analysis.No serial or lot number was provided by the customer to perform a device history record review.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The heartmate 3 lvas patient handbook (rev a), section 10 ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate3 lvad, including inspecting the driveline cable for signs of damage and ensuring that the modular in-line connector is secure and the connector locking nut is in the locked position.Heartmate 3 ifu (rev.D) section 2-¿system operations¿ and heartmate 3 patient handbook, section 2-¿how your heart pump works¿, explain that if it has been determined that damage has been detected in the modular cable, it should be replaced.Heartmate 3 lvas patient handbook, section 4 "living with the heartmate 3" (under "caring for the driveline"), contains information regarding how to clean and care for the driveline.This section instructs the user: "check the driveline daily for signs of damage (cuts, holes, tears).Call your hospital contact right away if the driveline is damaged (or might be damaged)." and "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." in addition, section 5 "alarms and troubleshooting" contains a sub-section entitled "what not to do: driveline and cables", which explicitly cautions the user not to twist.The patient handbook cautions the users 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24042052
• Report Number: 2916596-2026-00085
• Device Sequence Number: 10546954
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/23/2026
• 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 Age: 69 YR
• Patient Sex: Female