MalfunctionMCW
TURBO ELITE
Received Jul 6, 2011 · Event occurred Jun 23, 2011
Report 2182888 · MDR key 2182888
Device
Generic name
Catheter, Removal, Excimer, Electrode
Manufacturer
Spectranetics CorpModel number
414-151Catalog number
*
Lot number
F11C14E
Product problems
- Difficult to Insert
- Fitting Problem
Patient
55 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
TURBO ELITE CATHETER WOULD NOT PASS OVER 0.014" GUIDEWIRE. AT THE HUB AREA, WIRE PASSED THROUGH WHEN BACK LOADED BUT WAS TIGHT. NEW LASER CATHETER WAS OPENED AND USED WITHOUT DIFFICULTY.