NEEDLE'S EYE SNARE

Description of Event or Problem

THE FOLLOWING INFORMATION WAS RECEIVED REGARDING AN EVENT THAT OCCURRED: AN EXTRACTION OF A RIGHT ATRIAL (RA) LEAD THAT HAD BEEN IMPLANTED FOR 20 YEARS WAS PERFORMED. FROM THE LOWER EXTREMITY, A PHILIPS 16FR GLIDELIGHT LASER SHEATH WAS INSERTED WITHIN A GORE 18FR DRYSEAL SHEATH, AND AN LR-NES001 [NEEDLE'S EYE SNARE] WAS FURTHER ADVANCED INSIDE IT. THE RA LEAD WAS GRASPED AND ADVANCED, AND AFTER PERFORMING CT [COUNTERTRACTION] WITHIN THE ATRIUM USING THE 16FR GLIDELIGHT LASER SHEATH, THE LEAD WAS REMOVED. APPROXIMATELY 30 MINUTES LATER, INTRACARDIAC FLUID ACCUMULATION WAS DETECTED, SO DRAINAGE WAS PERFORMED. AFTER CONFIRMING THAT THERE WAS NO NEW BLEEDING, THE PATIENT WAS TRANSFERRED TO THE ICU. ADDITIONAL INFORMATION WAS REQUESTED AND LATER RECEIVED: COUNTERTRACTION USING THE LASER SHEATH IS CONSIDERED TO BE THE CAUSE. THE LR-NES001 WAS INSERTED THROUGH THE LASER SHEATH TO GRIP THE LEAD, AND THE LASER SHEATH WAS ADVANCED DISTALLY FROM THAT GRIPPING SITE TO DETACH THE LEAD AND THEN THE LEAD WAS PULLED USING THE LR-NES001.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR NOT APPLICABLE. THE SUBJECT DEVICE WAS NOT RETURNED FOR THIS EVENT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE CUSTOMER'S REPORTED EVENT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. AFTER FURTHER FOLLOW UP, IT WAS STATED THAT THE USE OF THE LASER SHEATH IS CONSIDERED TO BE THE CAUSE OF THE REPORTED EVENT. THERE WAS NO ALLEGATION OF A MALFUNCTION OF ANY COOK DEVICES. THE SPECIFIC MODEL NUMBER AND LOT NUMBER OF THE NEEDLE'S EYE SNARE WERE PROVIDED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THERE WERE NO SIGNS THAT THE DEVICE WAS NONCONFORMING OR THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS EVENT WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. PER THE DEVICE'S INSTRUCTIONS FOR USE: "PRIOR TO THE PROCEDURE, CONSIDER THE SIZE OF THE CATHETER/LEAD IN RELATION TO THE SIZE OF THE LEAD EXTRACTION¿ DEVICES TO DETERMINE POSSIBLE INCOMPATIBILITY.", "IF SELECTIVELY REMOVING CATHETERS/LEADS WITH THE INTENT TO LEAVE ONE OR MORE CHRONIC CATHETERS/LEADS IMPLANTED INTACT, THE NONTARGETED CATHETERS/LEADS MUST BE SUBSEQUENTLY TESTED TO ENSURE THAT THEY WERE NOT DAMAGED OR DISLODGED DURING THE EXTRACTION PROCEDURE.", "DO NOT USE EXCESSIVE FORCE TO GRASP AND PULL LARGE PORTIONS OF DOUBLED-OVER LEAD/CATHETER INTO THE 12 FR OR 16 FR SHEATH, AS IT COULD BECOME LODGED, PREVENTING FURTHER MOVEMENT OF THE SHEATHS OR SNARE(S).", "ESTABLISH BACK-UP PACING AS NECESSARY.", "HAVE AVAILABLE AN EXTENSIVE COLLECTION OF SHEATHS, LOCKING STYLETS, STYLETS TO UNSCREW ACTIVE FIXATION LEADS, SNARES, AND ACCESSORY EQUIPMENT.", "WHEN ADVANCING SHEATH(S) OVER THE CATHETER/LEAD, MAINTAIN ADEQUATE TENSION ON THE CATHETER/LEAD (VIA THE BASKET SNARE OR NEEDLE¿S EYE SNARE®) TO GUIDE THE SHEATH(S) AND PREVENT DAMAGE TO VESSEL WALLS.", "IF EXCESSIVE SCAR TISSUE OR CALCIFICATION PREVENTS SAFE ADVANCEMENT OF SHEATH(S), CONSIDER AN ALTERNATE APPROACH.", "EXCESSIVE FORCE WITH SHEATH(S) USED INTRAVASCULARLY MAY RESULT IN DAMAGE TO THE VASCULAR SYSTEM REQUIRING SURGICAL REPAIR.", "POTENTIAL ADVERSE EVENTS RELATED TO THE PROCEDURE OF INTRAVASCULAR EXTRACTION OF CATHETERS/LEADS INCLUDE (LISTED IN ORDER OF INCREASING POTENTIAL EFFECT): DISLODGING OR DAMAGING NONTARGETED CATHETER/LEAD, CHEST WALL HEMATOMA, THROMBOSIS, ARRHYTHMIAS, ACUTE BACTEREMIA, ACUTE HYPOTENSION, PNEUMOTHORAX, STROKE, MIGRATING FRAGMENT FROM CATHETER/OBJECT, PULMONARY EMBOLISM, LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM, HEMOPERICARDIUM /PERICARDIAL EFFUSION, CARDIAC TAMPONADE, HEMOTHORAX, CARDIAC ARREST, DEATH"., "CLINICAL EXPERIENCE IN THE REMOVAL OF LEADS HAS IDENTIFIED SEVERAL CONSIDERATIONS FOR LEAD REMOVAL TECHNIQUES USING SUPERIOR OR FEMORAL APPROACHES. PHYSICIANS HIGHLY EXPERIENCED WITH LEAD REMOVAL TECHNIQUES HAVE SUGGESTED THE FOLLOWING CONSIDERATIONS FOR REMOVAL OF LEADS, CATHETERS, OR OTHER INDWELLING OBJECTS.", "NOTE: TO PREVENT POTENTIAL COMPLICATIONS, CAREFULLY EXAMINE ANY BROKEN CATHETERS/LEADS. A LONG EXPOSED LEAD COIL COULD LACERATE THE HEART, OR A LOOSE FRAGMENT COULD MIGRATE, POSSIBLY INTO THE PULMONARY ARTERY. A PIGTAIL CATHETER OR CLOSED LOOP SNARE MAY BE USED TO RETRIEVE A CATHETER/LEAD FROM THE PULMONARY ARTERY, REPOSITIONING IT IN THE VENTRICLE FOR REMOVAL." THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO, A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.