BETA-CATH 3.5F SYSTEM
Received Dec 23, 2014 · Event occurred Dec 11, 2014
Report 4384678 · MDR key 4384678
Device
Generic name
Intravascular Radiation Delivery System
Manufacturer
Best Vascular, Inc.Model number
*Catalog number
*
Lot number
84025
Product problems
- Kinked
- Retraction Problem
Patient
63 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING THE BETA-CATH PROCEDURE (VASCULAR BRACHYTHERAPY), THE RADIOACTIVE STRONTIUM-90 SOURCE WAS NOT RETRACTED TO THE SAFE POSITION DUE TO THE CATHETER KINK AT THE END OF THE TREATMENT. THE WHOLE TREATMENT WAS DONE WITHOUT ANY DISCREPANCY BETWEEN PRESCRIBED AND DELIVERED DOSE. THE SOURCE WAS MANUALLY PLACED IN THE SHIELDED CONTAINER, AND CURRENTLY IS IN THE SHIELDED ROOM (HOT LAB). THE SOURCE IS ADDITIONALLY SHIELDED AND IT WILL BE SHIPPED TO THE VENDOR WHEN WE RECEIVE THE PROPER SHIELDING CONTAINER FROM THE VENDOR. THE MANUFACTURER IS SENDING A REPRESENTATIVE TO INSPECT THE DEVICE AND DETERMINE WHETHER THE SOURCES MAY BE SAFELY RETRACTED. THESE KINKS ARE KNOWN WITHIN THE FIELD.