LEAD EXTRACTION BULLDOG LEAD EXTENDER

Additional Manufacturer Narrative

INVESTIGATION/EVALUATION: DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY OF THE PRODUCT WAS CONDUCTED. NEITHER THE PRODUCT NOR IMAGES WERE RETURNED. THUS, A FULL INVESTIGATION COULD NOT BE PERFORMED. HOWEVER, BASED ON THE COMPLAINT REPORT THE DEVICE DID NOT CONTACT THE PATIENT IN SUCH A WAY AS TO CAUSE THE COMPLAINT EVENT. THERE WAS NOT ANY EVIDENCE OF MANUFACTURING NONCONFORMITY OR DEVICE MISUSE FOUND. THE ROOT CAUSE IS UNKNOWN. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

DURING A LEFT-SIDED LASER LEAD EXTRACTION TO REMOVE ONE NON-FUNCTIONAL RV LEAD (IMPLANTED 17 YEARS). THE LEAD WAS PREPPED WITH A COOK BULLDOG AND A 16 GIDELIGHT LASER SHEATH WAS USED TO EXTRACT. THE 16F SHEATH WAS USED AND THE EXTRACTION WENT SMOOTHLY. USING GENTLY TRACTION, THE LEAD WAS PULLED FREE. A CHUNK OF TISSUE CAME FREE WITH THE LEAD. AN EFFUSION WAS NOTED ON TEE. A STERNOTOMY WAS PERFORMED AND AN INJURY AT THE RV APEX WAS FOUND AND REPAIRED. A NEW BI-V SYSTEM WAS IMPLANTED AND THE PATIENT WAS DISCHARGED THE NEXT DAY. ADDITIONAL INFORMATION RECEIVED ON 23OCT2015: THE LEAD WAS IMPLANTED SOMETIME IN 1998 WITH PASSIVE FIXATION. LEAD WOULD NOT SUFFICIENTLY TAKE A LOCKING STYLET THROUGH INTERNAL LUMEN. A BULLDOG WAS ATTACHED AT THE PROXIMAL (EXPOSED) END OF THE LEAD AND SECURED WITH A ONE-TIE. ANOTHER MANUFACTURER'S 16FR GLIDELIGHT WAS PASSED OVER THE LEAD AND USED TO EXTRACT LEAD FROM THE RIGHT VENTRICLE, EXTRACTING OVER THE MAJORITY OF THE LEAD BODY. THE LEAD FREED FROM THE WALL OF THE RV TAKING A CHUNK OF TISSUE WHICH CAUSED THE WALL TO TEAR. PATIENT WAS PUT ON BYPASS WHILE CHEST WAS OPENED FOR REPAIR. THE DEVICE DID NOT GO INTO THE BODY AND THE DOCTOR BELIEVED THIS EVENT OCCURRED DUE TO THE PATIENT'S ANATOMY AND WAS NOT DEVICE RELATED.

Additional Manufacturer Narrative

THE EVENT IS CURRENTLY UNDER INVESTIGATION.

Description of Event or Problem

DURING A LEFT-SIDED LASER LEAD EXTRACTION TO REMOVE ONE NON-FUNCTIONAL RV LEAD (IMPLANTED 17 YEARS). THE LEAD WAS PREPPED WITH A COOK BULLDOG AND A 16 GLIDELIGHT LASER SHEATH WAS USED TO EXTRACT. THE 16F SHEATH WAS USED AND THE EXTRACTION WENT SMOOTHLY. USING GENTLY TRACTION, THE LEAD WAS PULLED FREE. A CHUNK OF TISSUE CAME FREE WITH THE LEAD. AN EFFUSION WAS NOTED ON TEE. A STERNOTOMY WAS PERFORMED AND AN INJURY AT THE RV APEX WAS FOUND AND REPAIRED. A NEW BI-V SYSTEM WAS IMPLANTED AND THE PATIENT WAS DISCHARGED THE NEXT DAY. ADDITIONAL INFORMATION RECEIVED ON 23OCT2015: THE LEAD WAS IMPLANTED SOMETIME IN 1998 WITH PASSIVE FIXATION. LEAD WOULD NOT SUFFICIENTLY TAKE A LOCKING STYLET THROUGH INTERNAL LUMEN. A BULLDOG WAS ATTACHED AT THE PROXIMAL (EXPOSED) END OF THE LEAD AND SECURED WITH A ONE-TIE. ANOTHER MANUFACTURER'S 16FR GLIDELIGHT WAS PASSED OVER THE LEAD AND USED TO EXTRACT LEAD FROM THE RIGHT VENTRICLE, EXTRACTING OVER THE MAJORITY OF THE LEAD BODY. THE LEAD FREED FROM THE WALL OF THE RV TAKING A CHUNK OF TISSUE WHICH CAUSED THE WALL TO TEAR. PATIENT WAS PUT ON BYPASS WHILE CHEST WAS OPENED FOR REPAIR. THE DEVICE DID NOT GO INTO THE BODY AND THE DOCTOR BELIEVED THIS EVENT OCCURRED DUE TO THE PATIENT'S ANATOMY AND WAS NOT DEVICE RELATED.