Description of Event or Problem · 1
DURING RIGHT HEART CATHETERIZATION, IT WAS DIFFICULT TO ADVANCE THE 7-FRENCH SWAN GANZ CATHETER. A 0.21 SWAN GUIDE WIRE WAS OPENED AND ATTEMPTED TO ADVANCE THROUGH THE SWAN GANZ BUT THE 0.21 WIRE WOULD NOT ADVANCE IN THE NORMAL FASHION. THE PHYSICIAN ALSO ATTEMPTED TO ADVANCE A SMALLER WIRE (0.14 WIRE) INTO THE SWAN GANZ, BUT THIS WIRE WOULD NOT ADVANCE EITHER. THE RIGHT HEART CATH PROCEDURE WAS CANCELLED. EARLIER IN 2012, EDWARDS ISSUED A RECALL OF NUMEROUS LOTS OF THIS DEVICE DUE TO THIS SAME ISSUE. THE EXPLANATION FROM THE MANUFACTURER WAS THAT A "VOID" HAD BEEN CREATED CAUSING AN OBSTRUCTION AND THEREFORE NOT ALLOWING THE GUIDE WIRE TO PASS. THE PROBLEM HAD REPORTEDLY BEEN CORRECTED. THE LAST PUBLISHED LOT NUMBER OF THE PREVIOUS RECALL ENDED WITH 8963. THE LOT NUMBER OF THIS PROBLEMATIC DEVICE WAS 8964. THE SAME PROBLEM WAS ALSO REPORTED WITH LOT NUMBER 8965. THROUGH DISCUSSIONS WITH THE MANUFACTURER, THE FACILITY LEARNED THE MANUFACTURER WAS APPROVED TO CONTINUE DISTRIBUTION OF THE DEVICE WITH ADDITIONAL INSTRUCTIONS FOR USE. THE FACILITY WAS UNAWARE OF THE MANUFACTURER'S CLEARANCE TO DO THIS. THE FACILITY WAS SENT 14 CASES OF LOT NUMBERS ENDING IN 8964 AND 8965 LAST MONTH. TO DATE, MORE RECENT LOT NUMBERS APPEAR TO WORK APPROPRIATELY, HOWEVER THE FACILITY IS CONTINUING TO MONITOR THIS ISSUE. THE MANUFACTURER IS REPLACING THE FACILITY'S INVENTORY OF ALL LOT NUMBERS ENDING IN 8964 AND 8965.