TURBO ELITE LASER ABLATION CATHETER
Received Jul 19, 2011 · Event occurred Jun 20, 2011
Report 1721279-2011-00040 · MDR key 2175653
Device
Generic name
2.3 Turbo Elite (te)
Manufacturer
Spectranetics Corp.Model number
423-001Catalog number
423-001
Lot number
FBC11D18B
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR
- Perforation of Vessels
Narrative
Description of Event or Problem
THIS WAS A VASCULAR INTERVENTION PROCEDURE PERFORMED IN THE OPERATING ROOM WITH THE INTENT OF RETURNING BLOOD FLOW TO THE RIGHT CFA. THE MD UTILIZED BOTH A QUICK CROSS SUPPORT CATHETER AND A 2.3 TURBO ELITE (TE) ABLATION CATHETER DURING THE CASE. AFTER LASING WITH THE TE, A PERFORATION WAS NOTED IN THE CFA VIA ANGIOGRAM. THE MD PROCEEDED TO SUCCESSFULLY BALLOON AND STENT THE VESSEL. THE PT'S VITAL SIGNS REMAINED STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF DEVICE MALFUNCTION FROM THE MD. DEVICE INSPECTION: UPON RECEIPT OF THE DEVICE, THERE WERE NO VISIBLE KINKS, LOOSE CONNECTIONS, BROKEN COMPONENTS, TIP DAMAGE, OR FIBER OPTIC COUPLER DAMAGE. THE FIBER BUNDLE WAS BRIGHT AND SHOWED NO SIGNS OF FRACTURED FIBERS. AN LHR REVIEW WAS NEGATIVE FOR ANY NON-CONFORMANCE OR ISSUES.