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	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 complete.
Event or Problem Description
It was reported that the patient's controller was recently exchanged on (b)(6) 2025 (pec-add cs-221210).The patient was ready to be discharged from hospital and was experiencing connect to power issues again.It appeared that the patient had spilled something on her brand-new controller.The modular cable connection also appeared to have residue.The batteries and clips were swapped and cleaned.Log file analysis was requested to assess current controller status.The event log file contained odd power cable disconnect alarms when the patient was utilizing battery power.These alarms appeared to be a result of rsoc (battery data) invalid flags.These types of alarms were typically caused by a poor connection between the batteries and clips.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the patient accidentally spilling liquid onto the modular cable, causing residue to appear on the cable, was not confirmed.The modular cable (lot number 10939548) was not returned for analysis.Questions regarding the event were asked multiple times and no responses were received.The root cause of the reported event appeared to have been user error, as it was reported that the patient accidentally spilled liquid onto the device.Review of the device history record for the modular cable, lot number 10939548, showed the device was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 patient handbook instructs users to never submerge their equipment, including their modular cable, underwater.The patient handbook also instructs users to never expose their equipment to liquids or fluids of any kind.The heartmate 3 patient handbook (section 4 ¿living with the heartmate 3¿ and section 6 ¿caring for the equipment¿) instructs users to regularly inspect their modular cables for signs of damage and to obtain a replacement if needed.Damage to the modular cable may interrupt pump operation.The heartmate 3 patient handbook also 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 (section titled ¿emergency contact list¿).The current revision of the patient handbook can be found on the eifu page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• 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: 23967004
• Report Number: 2916596-2025-08257
• Device Sequence Number: 4810049
• Product Code: DSQ
• UDI-Device Identifier: 05415067039385
• UDI-Public: (01)05415067039385(10)10939548(17)280707
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/27/2026

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: 10939548
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/10/2026; 02/26/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/23/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 133 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American