16F SLS AND LLD#2 SPECTRANETICS CORPORATION

INDICATION FOR PROCEDURE: EXTRACTION WAS DEEMED MEDICALLY NECESSARY IN ORDER TO PERFORM A MRI. PROCEDURE: LEFT SIDED EXTRACTION OF CLASS IIA, NON-FUNCTIONING LEADS PERFORMED IN THE CARDIAC CATHETER LAB. ORIGINAL IMPLANTATION DATE WAS (B) (6) 2000. ARTERIAL LINE PLACED AND FLUOROSCOPY WAS UTILIZED DURING THE CASE. MD ATTEMPTED LEAD RETRACTION BUT WAS UNSUCCESSFUL. MDT CLEARING STYLET WAS USED TO PREP BOTH A/V LEADS. LLD#2 WAS ATTACHED TO THE VENTRICULAR LEAD AND A LLD-EZ ON THE ATRIAL LEAD. THE 10YR OLD LEADS DID NOT COME OUT WITH GENTLE TRACTION SO A 14F SLS WAS USED TO LASE FOR 1 MINUTE, 38 SECONDS. UP SIZING TO A 16F SLS, LASING FOR 10 SECONDS BEFORE THE V-LEAD RELEASED. MD AGAIN BEGAN WITH THE 14F SLS, BUT UP SIZED TO 16F SLS FOR THE ATRIAL LEAD REMOVAL. THE PATIENT'S PRESSURE BEGAN DROPPING WHILE THE MD WAS REMOVING THE LEAD AND SLS. IMMEDIATE ACTION WAS TAKEN TO REPAIR THE SUSPECTED INJURY. TEAR AT IVC/R ATRIAL JUNCTION WAS REPAIRED. ANALYSIS: NO DEVICES WERE RETURNED TO THE MANUFACTURER AS THEY WERE DISPOSED OF DURING THE CODE. PATIENT OUTCOME: PATIENT RECOVERED AND WAS DISCHARGED.

MANUFACTURER DATES FOR ALL DEVICES: 500-012 - UNK, 500-013 - UNK, 518-019 - UNK, 518-067 - UNK.

ANALYSIS: NO DEVICES WERE RETURNED TO THE MANUFACTURER AS THEY WERE DISPOSED OF DURING THE CODE. THE SPNC REP WAS NOT PRESENT AT THIS CASE SO THEREFORE WAS UNABLE TO COLLECT THE DEVICES. LOT HISTORY REVIEW ON THE 16F SLS REVEALED NO ISSUES OR NONCONFORMANCES RELATED TO THE REPORTED EVENT. LOT HISTORY REVIEW WAS UNABLE TO BE PERFORMED ON THE LLD#2 DUE TO AN UNKNOWN SERIAL#. PATIENT'S OUTCOME: PATIENT EXPIRED. MANUFACTURER DATES FOR ALL DEVICES: 500-013/(B) (4): 04DECEMBER2009. 518-019/UNKNOWN: UNKNOWN.

INDICATION FOR PROCEDURE: ACUTE INFECTION POST RE-IMPLANTATION. PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE PERFORMED IN THE EP LAB UTILIZING BOTH AN ATRIAL LINE AND FLUOROSCOPY. THE PACER LEAD PLACED THE MONTH PRIOR WAS REMOVED WITHOUT DIFFICULTY. MD EASILY TRACKED OVER THE RV LEAD, THROUGH THE CLAVICULAR REGION WITH A 16F SLS. THE PATIENT HAD EXTENSIVE FIBROSIS ATTACHED TO THIS LEAD, BUT MD WAS ABLE TO PROGRESS TO THE SVC COIL WITHOUT MAJOR DIFFICULTY. PATIENT'S BLOOD PRESSURE WAS STABLE @ 91/62 THROUGHOUT THE PROCEDURE. AS THE MD PASSED THROUGH THE SVC ATRIAL JUNCTION INTO THE ATRIUM, THE PATIENT'S BLOOD PRESSURE DECREASED TO 80/56. MD STOPPED PROGRESSION IMMEDIATELY, GAVE THE PATIENT FLUIDS AND CONTACTED THE CT SURGEON WHO ARRIVED WITHIN 3 MINUTES OF THE PAGE. A STERNOTOMY WAS PERFORMED BY THE CT SURGEON WHILE THE MD REMAINED IN THE SAME POSITION CAREFUL NOT TO MOVE THE LASER CATHETER. THE SURGEON NOTED THE PATIENT HAD A 2-3CM TEAR AT THE SVC ATRIAL JUNCTION AS WELL AS A SVC TEAR HIGHER UP. PATIENT WENT INTO V-FIB DURING THE SVC REPAIR, WAS UNABLE TO BE PLACED ON BYPASS DUE TO THE LOCATION OF HIS INJURY.