MalfunctionMOU
30MM BETA-CATH DELIVERY CATHETER
Received Nov 19, 2001 · Event occurred Sep 6, 2001
Report 1062385-2001-00022 · MDR key 362798
Device
Generic name
Catheter
Manufacturer
Novoste CorporationModel number
510609-030Catalog number
BCK-0130
Lot number
454850
Product problems
- Migration or Expulsion of Device
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IN 2001, THE COMPLAINANT REPORTED THAT THE SOURCE TRAIN WAS OUTSIDE OF THE MARKER ON THE CATHETER. UPON RETURN OF THE PRODUCT AND EVALUATION OF IT (11/16/01), IT WAS DETERMINED THE MARKER BAND HAD MOVED APPROXIMATELY 5-7MM DISTAL FROM ITS ORIGINAL LOCATION.