MalfunctionMOU
40MM BETA-CATH DELIVERY CATHETER
Received Oct 16, 2002 · Event occurred Jul 22, 2002
Report 1062385-2002-00036 · MDR key 423476
Device
Generic name
Catheter
Manufacturer
Novoste Corp.Model number
510609-040Catalog number
BCK-0140
Lot number
475131
Product problems
- Displacement
- Kinked
- Device Damaged Prior to Use
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CATHETER WAS KINKED OUT OF THE BOX; HOWEVER UPON RECEIPT OF THE CATHETER AT NAVOSTE, IT WAS DETERMINDED THAT THE PROXIMAL MARKER BAND WAS DAMAGED AND HAD SHIFTED.