THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
Report
- Report Number
- 2916596-2026-01418
- Event Type
- Malfunction
- Date Received
- March 11, 2026
- Date of Event
- January 16, 2026
- Report Date
- March 11, 2026
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013181
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE COMMUNICATION FAULT ALARMS WAS CONFIRMED VIA THE SUBMITTED LOG FILE AND DURING EVALUATION OF THE RETURNED HEARTMATE MODULAR CABLE. DATA FROM THE REPORTED EVENT DATE 16JAN2026 FROM THE SUBMITTED AND DOWNLOADED LOG FILES WERE REVIEWED. THE CONTROLLER EVENT LOG FILES REVEALED A DRIVELINE COMMUNICATION FAULT ALARM ACTIVE FROM THE BEGINNING OF THE LOG FILES AND CLEARS AT 10:37:37. THE ALARM WAS ASSOCIATED WITH COM_A FAULTS. THE DRIVELINE IS DISCONNECTED AT 10:53:04 CONSISTENT WITH THE REPORTED CONTROLLER EXCHANGE. FOLLOW UP LOG FILES WERE SUBMITTED FOLLOWING THE CONTROLLER EXCHANGE AND REVEALED NO REOCCURRENCE OF THE ALARMS. THE RETURNED MODULAR CABLE, LOT NUMBER 9213778, WAS CONNECTED TO THE RETURNED SYSTEM CONTROLLER AND A MOCK CIRCULATORY LOOP FOR AN EXTENDED PERIOD. THE MODULAR CABLE WAS MANIPULATED BUT NO ATYPICAL ALARMS OR ISSUES WERE PRODUCED. THE RESISTANCE OF THE UNDERLYING WIRES OF THE MODULAR CABLE WAS TESTED AND DID NOT PASS. THE OUTER LAYERS WERE STRIPPED, AND THE GREEN (COMMUNICATION A) WIRE WAS REVEALED TO HAVE EXPOSED CONDUCTORS. UPON SLIGHT PULLING FORCE, THE GREEN WIRE BECAME EASILY SEVERED. THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED EVENT OF COM_A FAULTS. NO FURTHER TESTING WAS PERFORMED. A ROOT CAUSE FOR THE REPORTED DRIVELINE COMMUNICATION FAULTS WAS DETERMINED TO BE DAMAGE TO THE GREEN (COM_A) WIRE IN THE MODULAR CABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEAL THAT THE HEARTMATE MODULAR CABLE, LOT NUMBER 9213778, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 7 OF THE IFU, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INSTRUCTION ON HOW TO IDENTIFY AND TROUBLESHOOT DRIVELINE COMMUNICATION FAULT ALARMS. SECTION 5 OF THE IFU, ENTITLED ¿SURGICAL PROCEDURES¿ AND SECTION 6 OF THE IFU, ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ CAUTION USER TO AVOID TWISTS, KINKS, OR SHARP BENDS IN THE DRIVELINE. SECTION F OF THE IFU, ENTITLED ¿SAFETY CHECKLISTS¿ INSTRUCTS USERS TO INSPECT THE DRIVELINE FOR DAMAGE DAILY. 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.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A DRIVELINE COMMUNICATION FAULT ALARM. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED A DRIVELINE COMMUNICATION FAULT ALARM FLAG ASSOCIATED WITH A (F19) SYSTEM CONTROLLER FAULT FLAG COM_A_FAULT ON (B)(6) 2026. MOTOR FUNCTION WAS NOT AFFECTED BY THIS EVENT. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED, AND LOG FILES WERE SUBMITTED FOR REVIEW WHICH CONTAINED NO UNUSUAL EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637521 | THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE | Ventricular (assist) bypass | DSQ | THORATEC CORPORATION | 106525US | 9213778 | 00813024013181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female |