Description of Event or Problem · 1
PT WAS ADMITTED AS AN OUTPATIENT AND WAS SCHEDULED FOR A PTA. THE PT HAD PREVIOUSLY HAD A DIAGNOSTIC CARDIAC CATHETERIZATION AND PERIPHERAL ANGIOGRAM ON (B)(6) 2013. DURING THAT VISIT LEFT LEG FIXED FROM A RIGHT GROIN ACCESS. WHEN THE GUIDING ANGIOGRAM WAS TAKEN, A SHORT PIECE OF WHAT APPEARED TO BE A GUIDEWIRE TIP APPROX 3" LONG WAS NOTED IN THE L COMMON FEMORAL ARTERY. THE FOREIGN BODY WAS REMOVED THE NO PROBLEMS. ONCE INSPECTED OUTSIDE OF THE BODY, IT APPEARED TO BE THE TIP OF A GUIDEWIRE THAT HAD SHEARED OFF PROBABLY FROM THE PREVIOUS PROCEDURE. ONCE THE FOREIGN BODY HAD BEEN REMOVED, THE PT'S INTERVENTION WAS COMPLETED. THE PT EXPERIENCED NO COMPLICATIONS AND WAS DISCHARGED THE SAME DAY APPROX 3 HOURS LATER. THE RECORD FROM (B)(6) 2013, WAS REVIEWED AND THE GUIDE WIRE WAS NOTED TO BE AN ABBOTT VERSACORE .014 145CM GUIDEWIRE, REFERENCE #(B)(4). THE COMPANY SALES REP, WAS NOTIFIED AT ABBOTT VASCULAR, INC. (B)(4). F/U, A PROBLEM OCCURRED ON (B)(6) 2013, DURING A PROCEDURE WITH THE VERSACORE FLOPPY .014 145CM GUIDEWIRES. THE WIRE WAS BEING USED DURING THE DEPLOYMENT OF A PERCLOSE VASCULAR CLOSURE DEVICE. WHEN THE GUIDEWIRE WAS WITHDRAWN IT WAS NOTED THAT THE DISTAL END WAS UNRAVELED. ANOTHER VERSACORE GUIDEWIRE WAS OPENED AND THE SAME THING OCCURRED. THE WIRES WERE SAVED, THEY WERE REFERENCE #(B)(4), BOTH WERE LOT #3082301. ALL GUIDEWIRES WERE REMOVED FROM THE SHELF AND THE ABBOTT REP WAS NOTIFIED. SEE (B)(4) FOR FIRST EVENT.