MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, POWER MODULE PATIENT CABLE 14V; VENTRICULAR (ASSIST) BYPASS

Model Number	103426
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Electric Shock (2554); Presyncope (4410)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's power module power cable cords were frayed, and wires were exposed.While doing power changes, the patient was shocked.The power cable cords were replaced.Log files were obtained and upon interrogation there were not any noted alarms or parameters that were not within normal limits.The patient was not initially symptomatic, however after log files were obtained and the patient had been walking, the patient began to complain about feeling lightheaded.The patient lied down.There were no active alarms during the shock and the patient did not have an implantable cardioverter defibrillator (icd).Log files were submitted for review and did not capture any unusual events.The patient did not receive any more shocks once the power cords were replaced.
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 complete.
Additional Manufacturer Narrative
H5 - labeled for single use? - correction.H8 - usage of device - correction.Manufacturer's investigation conclusion: the reported event of damage to the heartmate 14v power module patient cable was confirmed via the submitted photos.The reported event of the patient being shocked was not confirmed as no product was returned.The submitted photos revealed damage to the outer jacket of the patient cable, exposing the underlying metal shield.The submitted log files did not indicate any issue with the patient cable.The provided information indicated there were no associated alarms, and no additional shocks have been received by the patient after the patient cable was exchanged.Multiple attempts were made to obtain additional information regarding confirmation of if the shock was from the patient cable or the system controller, the lot number of the patient cable, and if the patient cable would return; however, no additional information has been provided and to date, no product has been received for further analysis.A root cause for the reported events was not conclusively determined through this analysis; however, the damage to the patient cable could have contributed to the shock received by the patient.Device history records could not be reviewed due to the lot number of the heartmate 14v power module patient cable not being reported.The heartmate 3 instruction for use was available for use at the time of the event.Section 8, entitled ¿equipment storage and care¿, addresses how to properly care for, maintain, and store all equipment for proper use including the power module patient cable.The heartmate 3 patient handbook which was available for use at the time of the event, 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: HEARTMATE®, POWER MODULE PATIENT CABLE 14V
• 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: 21944041
• Report Number: 2916596-2025-02636
• Device Sequence Number: 8553821
• Product Code: DSQ
• UDI-Device Identifier: 00813024010784
• UDI-Public: (01)00813024010784
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 103426
• Device Catalogue Number: 103426
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic