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Patient 1
A LEAD EXTRACTION CASE COMMENCED TO REMOVE A NON-FUNCTIONAL RIGHT VENTRICLE (RV) LEAD. A RIGHT ATRIAL (RA) LEAD WAS ALSO PRESENT IN THE PATIENT BUT WAS NOT TARGETED FOR EXTRACTION. DURING PREPARATION TO REMOVED THE LEAD, A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS PLACED INSIDE THE RV LEAD AS A TRACTION PLATFORM. SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH WAS IN USE IN THE INNOMINATE REGION AND A GLIDELIGHT LASER SHEATH WAS IN USE IN THE SUBCLAVIAN REGION TO AID IN EXTRACTION. THE PHYSICIAN THEN CHOSE TO USE A COOK MEDICAL BYRD SHEATH TO RELEASE LEAD ON LEAD BINDING IN THE SUPERIOR VENA CAVA (SVC) REGION. AT THE TIME THE PHYSICIAN WAS USING THE COOK BYRD SHEATH, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE DEVICE AND STERNOTOMY. PERFORATIONS WERE IDENTIFIED IN THE SUPERIOR VENA CAVA (SVC) AND RIGHT ATRIAL (RA) JUNCTION. THE PERFORATIONS WERE REPAIRED SUCCESSFULLY, AND THE PATIENT SURVIVED THE PROCEDURE. DURING THE REPAIR, THE PHYSICIAN ATTEMPTED TO UNLOCK AND REMOVE THE LLD. WHEN THE ATTEMPT TO UNLOCK THE LLD WAS UNSUCCESSFUL, THE LLD AND RV LEAD WAS CUT, CAPPED, AND LEFT WITHIN THE PATIENT'S BODY. THIS REPORT IS BEING SUBMITTED TO CAPTURE THIS LLD DEVICE. NO SPECTRANETICS DEVICES WERE REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT INJURIES MENTIONED ABOVE.