DIREXION? TRANSEND?-14 SYSTEM
Report
- Report Number
- 2124215-2026-04462
- Event Type
- Malfunction
- Date Received
- January 26, 2026
- Date of Event
- December 30, 2025
- Report Date
- April 23, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KRA
- UDI-DI
- 08714729839774
- PMA / PMN Number
- K142259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1: (B)(6). G4: PREMARKET / 510(K) #: K142259, K163701.
E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. E1: INITIAL REPORTER PHONE: (B)(6). G4: PREMARKET / 510(K) #: K142259, K163701.
IT WAS REPORTED THAT MICROCATHETER FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER VESSEL. A NGMC/TRANSEND/021/BERN/1RO/130 DIREXION WAS SELECTED FOR USE. DURING THE INSERTION, IT WAS NOTED THAT THE MICROCATHETER WAS FRACTURED INSIDE PATIENT. 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 THE FRACTURE WAS LOCATED IN THE TAIL-END OF THE MICROCATHETER AND THE INNER LUMEN WAS STILL INTACT.
IT WAS REPORTED THAT MICROCATHETER FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER VESSEL. A NGMC/TRANSEND/021/BERN/1RO/130 DIREXION WAS SELECTED FOR USE. DURING THE INSERTION, IT WAS NOTED THAT THE MICROCATHETER WAS FRACTURED INSIDE PATIENT. 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 |
|---|---|---|---|---|---|---|---|
| 244498 | DIREXION? TRANSEND?-14 SYSTEM | CATHETER, CONTINUOUS FLUSH | KRA | BOSTON SCIENTIFIC CORPORATION | M001195840 | 0037354902 | 08714729839774 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male |