TURBO ELITE LASER ABLATION CATHETER
Received Apr 8, 2011 · Event occurred Mar 11, 2011
Report 1721279-2011-00023 · MDR key 2065822
Device
Generic name
1.7 Otw Turbo Elite
Manufacturer
Spectranetics Corp.Model number
410-152Catalog number
410-152
Lot number
F10F29C
Product problems
- Detachment Of Device Component
Patient
UNK
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
VERY LITTLE CASE INFORMATION IS KNOWN AT THIS TIME AND NO DEVICE(S) HAVE BEEN RETURNED FOR POST MARKET ANALYSIS. DURING A VASCULAR INTERVENTION CASE IT WAS NOTED ON FLUOROSCOPY THE DISTAL MARKER BAND OF THE 1.7 TE LASER ABLATION CATHETER BECAME DETACHED FROM THE DISTAL TIP OF THE CATHETER. UPON REMOVAL OF THE DEVICE, IT WAS CONFIRMED THE MARKER BAND REMAINED IN THE PATIENT. IT IS UNKNOWN WHAT THE SPECIFIC INTERVENTION WAS TO REMOVE THE MARKER BAND OR IF IT INDEED REMAINS IN THE PATIENT. FURTHER INVESTIGATION CONTINUES AND AN UPDATE WILL BE FORTHCOMING.