RAPTOR

Description of Event or Problem

LEAD EXTRACTION PROCEDURE TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD, AND (B)(6) LLD #2 LEAD LOCKING DEVICES (LLD) WERE BEING UTILIZED FOR TRACTION, ALONG WITH A (B)(6) 14F GLIDELIGHT LASER SHEATH. WHILE ATTEMPTING TO REMOVE THE RV LEAD, THE INNER LUMEN OF THE LEAD BROKE AWAY, AND THE LUMEN AND ENTIRE LLD WERE REMOVED FROM THE PATIENT. NEXT, THE RA LEAD WAS SUCCESSFULLY REMOVED. FOCUSING ATTENTION BACK TO THE RV LEAD REMNANT, MULTIPLE SNARES, BIOPTOMES, AND RAPTORS WERE THEN USED FROM A FEMORAL APPROACH TO ATTEMPT REMOVAL OF LEAD REMNANT. AFTER APPROXIMATELY 1.5 HOURS OF ATTEMPTING TO GRAB THE LEAD REMNANT, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED BELOW THE RIGHT VENTRICLE (RV). THE EFFUSION NEVER GREW IN SIZE, AND THE PATIENT REMAINED STABLE. HOWEVER, DUE TO POTENTIAL RISKS, A STERNOTOMY WAS PERFORMED TO REMOVE THE LEAD REMNANT. THE PATIENT SURVIVED THE PROCEDURE. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE SNARES, BIOPTOMES, OR RAPTORS. THE MANUFACTURERS OF THESE DEVICES ARE UNKNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORTS: MW5155601, MW5155603.