DIREXION?
Report
- Report Number
- 2124215-2025-56053
- Event Type
- Malfunction
- Date Received
- August 19, 2025
- Date of Event
- July 15, 2025
- Report Date
- October 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
A4: WEIGHT: 75 G. E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6). G4: PREMARKET/510(K) #: K142259, K163701.
A4 - WEIGHT: 75 G. E1 - INITIAL REPORTER FACILITY NAME: (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. VISUAL EXAMINATION DID NOT REVEAL ANY PROBLEMS WITH THE MICROCATHETER. FUNCTIONAL TESTING WAS COMPLETED BY INSERTING A GUIDEWIRE AND NO ISSUES WERE MET WHEN THE GUIDEWIRE WAS FULLY INSERTED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.
A4 - WEIGHT: 75 G. E1 - INITIAL REPORTER FACILITY NAME: (B)(6). 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 A VESSEL OUTSIDE OF THE NECK. A DIREXION MICROCATHETER WAS SELECTED FOR USE FOR ARTERIOVENOUS MALFORMATION. DURING PROCEDURE, IN ATTEMPT TO DEPLOY THE COIL, THE COIL COULD NOT BE ADVANCED AFTER REPEATED ATTEMPTS. UPON FURTHER EXAMINATION, IT WAS FOUND THAT THE MICROCATHETER WAS FRACTURED AND COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE FRACTURE WAS LOCATED IN THE CONNECTION BETWEEN CATHETER AND TORQUER.
IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL OUTSIDE OF THE NECK. A DIREXION MICROCATHETER WAS SELECTED FOR USE FOR ARTERIOVENOUS MALFORMATION. DURING PROCEDURE, IN ATTEMPT TO DEPLOY THE COIL, THE COIL COULD NOT BE ADVANCED AFTER REPEATED ATTEMPTS. UPON FURTHER EXAMINATION, IT WAS FOUND THAT THE MICROCATHETER WAS FRACTURED AND COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE FRACTURE WAS LOCATED IN THE CONNECTION BETWEEN CATHETER AND TORQUER.
IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL OUTSIDE OF THE NECK. A DIREXION MICROCATHETER WAS SELECTED FOR USE FOR ARTERIOVENOUS MALFORMATION. DURING PROCEDURE, IN ATTEMPT TO DEPLOY THE COIL, THE COIL COULD NOT BE ADVANCED AFTER REPEATED ATTEMPTS. UPON FURTHER EXAMINATION, IT WAS FOUND THAT THE MICROCATHETER WAS FRACTURED AND COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253068 | DIREXION? | CATHETER, CONTINUOUS FLUSH | KRA | BOSTON SCIENTIFIC CORPORATION | M001195240 | 0035156183 | 08714729839354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Male |