DIREXION?
Report
- Report Number
- 2124215-2025-56054
- Event Type
- Malfunction
- Date Received
- August 19, 2025
- Date of Event
- July 9, 2025
- Report Date
- November 10, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KRA
- UDI-DI
- 08714729839354
- PMA / PMN Number
- K142259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1 - INITIAL REPORTER ZIP/POST CODE: UPDATED. E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701. H6 - DEVICE CODES: UPDATED. DEVICE EVALUATED BY MFR: THE DIREXION MICROCATHETER WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. DURING VISUAL INSPECTION A FRACTURE WAS FOUND ON THE NICKEL SHAFT 22CM FROM THE STRAIN RELIEF, IT WAS ALSO FOUND THAT THERE WAS A KINK IN THE INNER SHAFT WHERE THE FACTURE IS. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS CONFIRMED THE REPORTED COMPLAINT.
E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701.
E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701.
IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN A FEMORAL ARTERY EMBOLISM. DURING THE PROCEDURE, UPON ADJUSTING THE DIRECTION OF THE MICROCATHETER, THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT A FRACTURE OCCURRED IN THE MIDDLE OF THE MICROCATHETER. THE INNER CAVITY REMAINED INTACT, WITH ONLY THE NICKEL ROD WAS FRACTURED AND THE SHAPING MANDREL STILL IN PLACE INSIDE THE TIP.
IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN A FEMORAL ARTERY EMBOLISM. DURING THE PROCEDURE, UPON ADJUSTING THE DIRECTION OF THE MICROCATHETER, THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS STABLE POST PROCEDURE.
IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN A FEMORAL ARTERY EMBOLISM. DURING THE PROCEDURE, UPON ADJUSTING THE DIRECTION OF THE MICROCATHETER, THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT A FRACTURE OCCURRED IN THE MIDDLE OF THE MICROCATHETER. THE INNER CAVITY REMAINED INTACT, WITH ONLY THE NICKEL ROD WAS FRACTURED AND THE SHAPING MANDREL STILL IN PLACE INSIDE THE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2636042 | DIREXION? | CATHETER, CONTINUOUS FLUSH | KRA | BOSTON SCIENTIFIC CORPORATION | M001195240 | 0035736231 | 08714729839354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male |