THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
Report
- Report Number
- 2916596-2024-04789
- Event Type
- Malfunction
- Date Received
- July 30, 2024
- Date of Event
- July 12, 2024
- Report Date
- October 2, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013181
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
SECTION D4: MODEL NUMBER AND CATALOG NUMBER CORRECTED. SECTIONS D4 AND H4: EXPIRATION DATE AND MANUFACTURING DATE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF SUPERFICIAL DAMAGE TO THE MODULAR CABLE WAS CONFIRMED THROUGH REVIEW OF THE SUBMITTED IMAGE; HOWEVER, A SPECIFIC CAUSE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, THE REPORT OF DEBRIS ON THE INLINE CONNECTOR COULD NOT BE CONFIRMED AS THE INLINE CONNECTOR WAS NOT CAPTURED IN THE SUBMITTED IMAGE AND THE MODULAR CABLE WAS DISCARDED BY THE ACCOUNT. THE ACCOUNT SUBMITTED AN IMAGE SHOWING A TEAR IN THE MODULAR CABLE OUTER JACKET, REVEALING THE UNDERLYING ARMOR LAYER. NO WIRES WERE VISIBLE. THE MODULAR CABLE, LOT #7802060, WAS EXCHANGED AND DISCARDED BY THE ACCOUNT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS THE HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 6 OF THIS DOCUMENT CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS IFU FURTHER EMPHASIZES NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, OR MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF THE EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE PUMP TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN. SECTION 6 (UNDER "CARING FOR THE DRIVELINE") ALSO INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 7 OF THIS IFU PROVIDES ADDITIONAL INSTRUCTION REGARDING THE DRIVELINE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." FINALLY, SECTION 8 EXPLAINS THAT AS NEEDED, THE USER CAN CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, ALSO CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE, INCLUDING A SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE CONNECTION WAS CLEANED AND THE MODULAR CABLE WAS ABLE TO BE DISCONNECTED FROM THE DRIVELINE. THE MODULAR CABLE WAS REPLACED.
IT WAS REPORTED THAT THE PATIENT HAD A SEVERELY DAMAGED DRIVELINE AND MODULAR CABLE. THERE SEEMED TO BE SOMETHING THAT SPILLED AND DRIED ON THE CONNECTOR MAKING IT IMPOSSIBLE TO UNSCREW. ALCOHOL WIPES WERE USED TO REMOVE THE CONTAMINANT BUT THE CONNECTOR WOULD NOT UNSCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1733611 | THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106525US | 7802060 | 00813024013181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male |