MalfunctionMOU
NOVOSTE B-RAIL
Received Jul 2, 2013 · Event occurred Apr 30, 2013
Report 3225999 · MDR key 3225999
Device
Generic name
Brachy Catheter
Manufacturer
Best Vascular, IncModel number
*Catalog number
ABR-0346
Lot number
BW0135
Product problems
- Kinked
- Activation, Positioning or Separation Problem
Patient
73 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE SURGEON WAS UNABLE TO CORRECTLY DEPLOY BRACHYTHERAPY CATHETER (ABR-0346) AS THERE WAS A 'KINK' IN THE CATHETER. ANOTHER CATHETER HAD TO BE USED. NO IMPACT TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CATHETERIZATION WITH ANGIOGRAPHY FOLLOWED BY INTRAVASCULAR BRACHYTHERAPY DUE TO THE PROXIMAL AND DISTAL STENOTIC PORTION OF THE RIGHT FEMORAL POPLITEAL GRAFT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.