Description of Event or Problem · 1
CLINICAL HISTORY: PT IS A FEMALE OF UNK WEIGHT AND AGE, SCHEDULED FOR A LEAD REMOVAL SECONDARY TO MALFUNCTIONING PACEMAKER LE. PROCEDURE: DR. WAS PERFORMING A LEFT-SIDED, LEAD REMOVAL OF TWO LEADS THAT WERE CONNECTED TO THE PACEMAKER ON THE LEFT AND AN ABANDONED RIGHT-SIDED LEAD. DR. HAD PERFORMED OVER 100 LEAD REMOVAL CASES. THE MD PLACED A PACING STYLET IN BOTH THE A AND V LEADS. HE DETERMINED THE LEADS COULD NOT BE REMOVED WITH GENTLE TRACTION, THE LEADS WERE CUT AND A LLD-EZ WAS PLACED IN EACH LEAD. A 14F SLS II WAS INTRODUCED OVER ONE OF THE LEADS. FLUOROSCOPY, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND AN ATERIAL LINE WERE USED THROUGHOUT THE PROCEDURE. THE MD EXPERIENCED DIFFICULTY ADVANCING THE SLS II PRIOR TO THE SVC. UPON APPLYING ADDITIONAL TRACTION ON THE LEAD, THE LLD-EZ BROKE OFF AT THE MANDREL. AT THAT POINT, THE SLS II WAS REMOVED AND THE LASER WAS PLACED IN STANDBY MODE. THE MD THEN OBTAINED A COOK EVOLUTION DEVICE THAT WAS INTRODUCED OVER THE TARGET LEAD. THE COOK DEVICE WAS ADVANCED OVER THE LEAD PAST THE POINT THAT THE LASER HAD GONE. SOON AFTER, IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURE HAD DROPPED. AT THAT POINT, DR. OBSERVED THE TEE MONITOR. AS THE MEDICAL STAFF WAS TREATING THE PATIENT'S COMPLICATION, THE SPNC REPRESENTATIVE UNPLUGGED THE 14F SLS II FROM THE CVX-300, UNPLUGGED THE FOOT PEDAL AND CORD, AND REMOVED THEM FROM THE ROOM IN ORDER TO ALLOW THE MEDICAL STAFF TO FOCUS ON THE PATIENT. THE SPNC REPRESENTATIVE DID NOT RE-ENTER THE ROOM. CHEST COMPRESSIONS WERE STARTED AS THE REPRESENTATIVE WAS EXITING. THE CARDIOTHORACIC SURGEON WAS IMMEDIATELY AVAILABLE. PATIENT OUTCOME: DEATH. FAILURE ANALYSIS: THERE WERE NO DEVICES RETURNED FOR FAILURE ANALYSIS. THERE IS NO INDICATION THAT THE EVENT WAS CAUSED BY A MALFUNCTION OF THE SPNC DEVICES. WILL PROVIDE FOLLOW-UP INFORMATION (PT'S WEIGHT AND AGE) IF ABLE TO OBTAIN FROM THE CUSTOMER.