LLD E LEAD LOCKING DEVICE

Description of Event or Problem

A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A LEFT VENTRICULAR (LV) AND RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. A SPECTRANETICS LLD E LEAD LOCKING DEVICE (LLD E) WAS INSERTED INTO THE LV LEAD, AND A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE LV LEAD, HEAVY BINDING SITES WERE ENCOUNTERED. NEXT, TARGETING THE RV LEAD WITH THE 14F GLIDELIGHT, PROGRESS STALLED AND SWITCHED TO A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE LV AND RV LEAD. THEN, UTILIZING THE 14F GLIDELIGHT ON THE LV LEAD, ADVANCEMENT WAS MADE DOWN THE CORONARY SINUS (CS), PAST THE SUPERIOR VENA CAVA (SVC), WHEN PROGRESS STALLED AGAIN. SWITCHING TO THE RV LEAD WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ADVANCEMENT STALLED IN THE SVC; THEREFORE, A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED, AND MADE IT PAST THE SVC WHEN THE RV LEAD BROKE. THE INTACT LLD EZ, ALONG WITH A PORTION OF THE RV LEAD WERE REMOVED FROM THE PATIENT. MOVING BACK THE LV LEAD WITH THE 14F GLIDELIGHT, PROGRESS WAS MADE PAST THE SVC DOWN TO THE CS, AND WHILE PULLING TRACTION WITH THE LLD E, THE LEAD WAS REMOVED; HOWEVER, A PERICARDIAL EFFUSION WAS DETECTED AND THE PATIENT¿S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. A CS PERFORATION WAS DISCOVERED AND REPAIRED, AND THE DISTAL TIP OF THE RV LEAD REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD E PROVIDING TRACTION ON THE LV LEAD WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

Additional Manufacturer Narrative

A3B) PATIENT GENDER - NOT AVAILABLE FROM FACILITY. H3) THE LLD E WAS DISCARDED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. H6) PER IFU, PERFORATION IS LISTED AS A POTENTIAL ADVERSE EVENT WITH USE OF THE LLD DEVICE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.