InjuryHAM
INSITUCAR (R) VALVULOTOME
Received Mar 18, 1994 · Event occurred Feb 15, 1994
Report 2916714-1994-00004 · MDR key 14326
Device
Generic name
Valve Cutter
Manufacturer
Braun MedicalModel number
NACatalog number
5521114
Lot number
2/3084
Product problems
- Tip breakage
Patient
*
Narrative
Description of Event or Problem
DURING A SURGICAL PROCEDURE, THE INSITUCAT VALVULOTOME TIP CAME OFF IN SITU. THE TIP WAS EXTRACTED THROUGH A SURRGICAL INCISION. ANOTHER INSITUCAT DEVICE WAS OBTAINED AAAAAND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.