LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

Description of Event or Problem

WE RECEIVED THE FOLLOWING INFORMATION FROM A THIRD PARTY ON BEHALF OF THE CUSTOMER: THE CUSTOMER REPORTED THEY WERE DOING AN EXTRACTION USING OUR TOOLS AND AS THEY WERE EXTRACTING THE RA LEAD, THEY BELIEVE THERE WAS A PERFORATION IN THE RIGHT ATRIUM. FURTHER FOLLOW-UP INFORMATION WAS LATER PROVIDED BY THE DR. THE DR. REPORTED THAT THE PATIENT EXPIRED ON THE TABLE AND THE LEAD WAS OVER 20 YEARS OLD.

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS NOT RETURNED. THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THERE WAS NO ALLEGATION OR EVIDENCE OF A DEVICE MALFUNCTION OF A COOK PRODUCT. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS EVENT IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. PER THE MANUFACTURER'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.", "HAVE AVAILABLE AN EXTENSIVE COLLECTION OF SHEATHS, LOCKING STYLETS, STYLETS TO UNSCREW ACTIVE FIXATION LEADS, SNARES, AND ACCESSORY EQUIPMENT.", "IF EXCESSIVE SCAR TISSUE OR CALCIFICATION PREVENTS SAFE ADVANCEMENT OF SHEATH(S), CONSIDER AN ALTERNATE APPROACH.", "DUE TO RAPIDLY EVOLVING CATHETER/LEAD TECHNOLOGY, THIS DEVICE MAY NOT BE SUITABLE FOR THE REMOVAL OF ALL TYPES OF CATHETERS/LEADS. IF THERE ARE QUESTIONS OR CONCERNS REGARDING COMPATIBILITY OF THIS DEVICE WITH PARTICULAR CATHETERS/LEADS, CONTACT THE CATHETER/LEAD MANUFACTURER.", "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.", "WARNINGS: "WHEN USING SHEATHS, DO NOT INSERT SHEATHS OVER MORE THAN ONE LEAD AT A TIME. SEVERE VESSEL DAMAGE, INCLUDING VENOUS WALL LACERATION REQUIRING SURGICAL REPAIR, MAY OCCUR.", "ESTABLISH BACK UP PACING AS NECESSARY.", "WHEN ADVANCING SHEATHS INCLUDING THE EVOLUTION OR EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, USE PROPER SHEATH TECHNIQUE AND MAINTAIN ADEQUATE TENSION ON THE CATHETER/LEAD (VIA A LOCKING STYLET OR DIRECTLY) TO AVOID DAMAGE TO VESSEL WALLS.", "EXCESSIVE FORCE WITH SHEATHS, INCLUDING THE EVOLUTION OR EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET USED INTRAVASCULARLY MAY RESULT IN DAMAGE TO THE VASCULAR SYSTEM REQUIRING SURGICAL REPAIR.", "IF THE CATHETER/LEAD BREAKS, EVALUATE FRAGMENT; RETRIEVE AS INDICATED.", "IF HYPOTENSION DEVELOPS, RAPIDLY EVALUATE; TREAT AS APPROPRIATE."", "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." 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.