InjuryMOU
BEST VASCULAR INC NOVOSTE B-RAIL DELIVERY CATH
Received May 28, 2021 · Event occurred Feb 25, 2021
Report MW5101623 · MDR key 11912477
Device
Generic name
Intravascular Radiation Delivery System
Manufacturer
Best Vascular IncProduct problems
- Break
- Entrapment of Device
- Detachment of Device or Device Component
Patient
87 YR
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
PRODUCT WAS USED TO DELIVER RADIATION FOR BRACHYTHERAPY. UPON INSPECTION OF THE DEVICE FOLLOWING THE PROCEDURE IT WAS NOTED THAT THE TIP OF THE CATHETER WAS MISSING AND HAD BECOME DETACHED IN THE PATIENT'S BLOOD VESSEL. FDA SAFETY REPORT ID# (B)(4).