HEARTMATE GOGEAR CONSOLIDATED BAG, LEFT
Report
- Report Number
- 2916596-2025-05772
- Event Type
- Malfunction
- Date Received
- September 3, 2025
- Date of Event
- August 28, 2025
- Report Date
- October 2, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024011279
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 COMPLETE.
SECTION H5/H9: USAGE OF DEVICE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE GOGEAR CONSOLIDATED BAG HAVING A DISLODGED SNAPHOOK WAS CONFIRMED, AS THE RETURNED CONSOLIDATED BAG (LOT NUMBER 9213649) WAS OBSERVED TO HAVE ONE OF ITS SNAPHOOKS MISSING FROM ITS RESPECTIVE D-RING UPON ARRIVAL. T THE FITTING HOLE OF THE SHOULDER STRAP D-RING WAS OBSERVED TO BE SLIGHTLY WORN WHICH APPEARED TO BE CONSISTENT WITH NORMAL USE WEAR. WEAR OF THE D-RING OVER TIME APPEARED TO RESULT IN MATERIAL FATIGUE AND MISSHAPING OF THE HOLE, WHICH COULD HAVE CONTRIBUTED TO THE SNAPHOOK DISLODGING FROM ITS INTENDED POSITION. THE CONNECTION OF THE OTHER CARABINER CLIP WAS UNREMARKABLE. THE CONSOLIDATED BAG ZIPPERS, CONTROLLER POCKET BUCKLE, AND THE SHOULDER STRAP CONNECTION OF THE SIDE WITH THE INTACT CARABINER CLIP WERE TESTED AND FUNCTIONED AS INTENDED. A MANUFACTURING ANALYSIS TASK WAS COMPLETED TO ADDRESS THE REPORTED EVENT FURTHER. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO NOTIFY THE SUPPLIER OF THE REPORTED EVENT AS A RESULT OF THE MANUFACTURING ANALYSIS TASK. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE SUPPLIER-RELATED. DEVICE HISTORY RECORDS WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), AND PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, AND SECTION 4 OF THE PATIENT HANDBOOK, ¿LIVING WITH THE HEARTMATE 3¿, PROVIDE INSTRUCTIONS AND IMAGES FOR HOW TO PROPERLY PUT ON, USE, AND TAKE OFF THE CONSOLIDATED BAG. SECTION 8 OF THE IFU, ¿EQUIPMENT STORAGE AND CARE¿, AND SECTION 6 OF THE PATIENT HANDBOOK, ¿EQUIPMENT MAINTENANCE¿, INSTRUCT THE USER TO PERIODICALLY INSPECT THE WEAR AND CARRY ACCESSORIES FOR DAMAGE OR WEAR. THESE SECTIONS FURTHER STATE, ¿IF AN ACCESSORY APPEARS DAMAGED OR WORN, DO NOT USE IT. CONTACT THE MANUFACTURER WITH QUESTIONS OR TO ORDER A REPLACEMENT, IF NEEDED.¿ 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 COMPLETE.
IT WAS REPORTED THAT THE METAL CARABINER BROKE OFF FROM THE METAL EYELET HOLDER CAUSING THE CARRYING STRAP TO BECOME INSUFFICIENT AND THE HEARTMATE 3 SYSTEM TO FALL OFF, RESULTING IN TENSION AT THE DRIVELINE EXIT SITE AND ACCOMPANYING BLEEDING. THE BAG WAS REPLACED.
IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD ONLY MICRO BLEEDINGS DUE TO SMALL SKIN LESIONS AROUND THE EXIT SITE WHICH WERE DUE TO THE TENSION OF THE DRIVELINE DURING THE FALL OF THE BAG. THE PATIENT WAS TREATED WITH CLOTTING DRESSINGS, AND THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2331116 | HEARTMATE GOGEAR CONSOLIDATED BAG, LEFT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106449 | 9213649 | 00813024011279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |