DIREXION?
Report
- Report Number
- 2124215-2025-25295
- Event Type
- Malfunction
- Date Received
- May 2, 2025
- Date of Event
- April 2, 2025
- Report Date
- June 30, 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 FACILITY NAME: (B)(6). E1 - INITIAL REPORTER ADDRESS 1: (B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701.
E1 - INITIAL REPORTER FACILITY NAME: (B)(6). E1 - INITIAL REPORTER ADDRESS 1: (B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701.
E1 - (B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701. DEVICE EVALUATED BY MFR: THE DIREXION MICROCATHETER WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION REVEALED NICKEL SHAFT FRACTURE AT THE STRAIN RELIEF. MICROSCOPIC EXAMINATION REVEALED INNER LUMEN KINKED AND STRETCHED APPROXIMATELY .5CM FROM THE NICKEL SHAFT FRACTURE SITE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.
IT WAS REPORTED THAT THE FRONT PART OF THE MICROCATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A NGMC/SINGLE/021/BERN/1RO/130 DIREXION MICROCATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE FRONT PART OF THE MICRO CATHETER 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 FURTHER REPORTED THAT IT WAS THE NICKEL JACKET OF THE TIP THAT WAS FRACTURED WITH THE INNER LINER STILL INTACT. THE FRACTURE OCCURRED AT 0.5CM FROM THE HUB WHICH COULD NEVER ENTER THE PATIENT'S BODY.
IT WAS REPORTED THAT THE FRONT PART OF THE MICROCATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A NGMC/SINGLE/021/BERN/1RO/130 DIREXION MICROCATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE FRONT PART OF THE MICRO CATHETER 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 THE FRONT PART OF THE MICROCATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A NGMC/SINGLE/021/BERN/1RO/130 DIREXION MICROCATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE FRONT PART OF THE MICRO CATHETER 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 FURTHER REPORTED THAT IT WAS THE NICKEL JACKET OF THE TIP THAT WAS FRACTURED WITH THE INNER LINER STILL INTACT. THE FRACTURE OCCURRED AT 0.5CM FROM THE HUB WHICH COULD NEVER ENTER THE PATIENT'S BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189614 | DIREXION? | CATHETER, CONTINUOUS FLUSH | KRA | BOSTON SCIENTIFIC CORPORATION | M001195240 | 0035123973 | 08714729839354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Male |