DIREXION HI-FLO FATHOM-16 SYSTEM
Report
- Report Number
- 2124215-2025-07829
- Event Type
- Malfunction
- Date Received
- February 13, 2025
- Date of Event
- January 10, 2025
- Report Date
- March 19, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KRA
- UDI-DI
- 08714729839712
- PMA / PMN Number
- K142259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4 - ADDITIONAL PREMARKET / 510(K): K163701.
G4 - PREMARKET / 510(K): K142259, K163701.
IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A VESSEL OF THE LIVER FOR A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING INSERTION, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.
IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A VESSEL OF THE LIVER FOR A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING INSERTION, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS FRACTURED AT THE TIP OF HUB, AND 3CM FROM THE TIP. THE INNER LUMEN WAS STILL INTACT, AND ONLY THE NICKEL SHAFT WAS FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 867765 | DIREXION HI-FLO FATHOM-16 SYSTEM | CATHETER, CONTINUOUS FLUSH | KRA | BOSTON SCIENTIFIC CORPORATION | M001195740 | 0034932875 | 08714729839712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male |