DIREXION? HI-FLO?
Report
- Report Number
- 2124215-2025-55384
- Event Type
- Malfunction
- Date Received
- August 11, 2025
- Date of Event
- July 10, 2025
- Report Date
- December 17, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KRA
- UDI-DI
- 08714729839576
- PMA / PMN Number
- K142259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6 - DEVICE CODES: UPDATED FROM DETACHMENT OF DEVICE OR DEVICE COMPONENT TO MATERIAL INTEGRITY PROBLEM. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701.
(B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701. DEVICE EVALUATED BY MFR: THE DIREXION MICROCATHETER WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. DURING VISUAL INSPECTION IT WAS FOUND THAT THE CATHETER WAS SEPARATED AT THE HUB. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE SITE PROVIDED A PHOTO. THE PHOTO SUBMITTED REVEALED A COMPLETE SEPARATION OF THE SHAFT FROM THE HUB.
(B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701.
E1 - INITIAL REPORTER ADDRESS 1: (B)(6). E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701. DEVICE EVALUATED BY MFR: THE DIREXION MICROCATHETER WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. DURING VISUAL INSPECTION IT WAS FOUND THAT THE CATHETER WAS SEPARATED AT THE HUB. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE SITE PROVIDED A PHOTO. THE PHOTO SUBMITTED REVEALED A COMPLETE SEPARATION OF THE SHAFT FROM THE HUB.
IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT THE ENTIRE TIP WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT THE ENTIRE TIP WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT THE ENTIRE TIP WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT THE ENTIRE TIP WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2007007 | DIREXION? HI-FLO? | CATHETER, CONTINUOUS FLUSH | KRA | BOSTON SCIENTIFIC CORPORATION | M001195500 | 0036176666 | 08714729839576 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male |