MalfunctionNUI
LYSUS INFUSION CATHETER
Received Apr 11, 2007 · Event occurred Mar 8, 2007
Report 839568 · MDR key 839568
Device
Generic name
Catheter, Iv
Manufacturer
Ekos CorporationModel number
060725062-004Catalog number
500-52118
Lot number
*
Product problems
- Device Issue
- Device, removal of (non-implant)
Patient
81 YR
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
AN EKOS LYSUS INFUSION CATHETER WAS PLACED IN THE PATIENT. FOUR HOURS LATER, THE ULTRASONIC CORE HAD FAILED. THE PATIENT WAS RETURNED TO INTERVENTIONAL RADIOLOGY WHERE THE CATHETER WAS SUCCESSFULLY REMOVED AND REPLACED WITH A NEW DEVICE.