MalfunctionMOU
40MM BETA-CATH DELIVERY CATHETER
Received Jan 2, 2003 · Event occurred Dec 13, 2002
Report 1062385-2002-00043 · MDR key 436346
Device
Generic name
Catheter
Manufacturer
Novoste Corp.Model number
510609-040Catalog number
BCK-0140
Lot number
UNK
Product problems
- Material Puncture/Hole
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINANT REPORTED THAT THE 40MM BETA-CATH DELIVE3RY CATHETER WAS PUNCTURED. THE SITE REPORTED THAT THE CATHETER WAS PUNCTURED POSSIBLY FROM THE STENT. NO PT ADVERSE EVENT WAS REPORTED.
Description of Event or Problem
THE 40MM BETA-CATH DELIVERY CATHETER WAS PUNCTURED. THE SITE REPORTED THAT THE CATHETER WAS PUNCTURED POSSIBLY FROM THE STENT. NO PT ADVERSE EVENT WAS REPORTED.