SOLITAIRE INTRODUCER SHEATH

Description of Event or Problem

DURING A STROKE CASE WHEN A APRO SWIFT CATHETER WAS BEING EXTRACTED FROM THE INTRODUCER SHEATH IT STARTED TO UNRAVEL AND HAD PLASTIC COMING WITH IT. THE EVENTS LEADING UP TO THE PROCEDURE INCIDENT WERE AS FOLLOWS: 1 BALT BALLAST INTRODUCER SHEATH WAS INTRODUCED INTO THE RIGHT ICA. LOT F251200867 REF (B)(4) MEDTRONIC APRO 70 SWIFT CATHETER 132CM WAS INTRODUCED THROUGH THE GUIDE SHEATH. LOT JL25-007 REF (B)(4) MEDTRONIC SOLITAIRE 4X40 WAS INTRODUCED INTO THE SHEATH. LOT D002067 REF (B)(4) UPON REMOVAL, THE APRO STARTED TO 'UNRAVEL' AND BITS OF PLASTIC CAME WITH IT AND THEY STOPPED. 5 THE SOLITAIRE WAS UNABLE TO BE RETRIEVED 6 THE INTRODUCER SHEATH WITH ALL ITEMS HAD TO BE REMOVED TOGETHER, WHICH ISN'T IDEAL. UPON REMOVAL OF THE ITEMS IN ONE UNIT IT WAS NOTICED THE APRO WAS FRAYED. THE PATIENT SUFFERED DAMAGE FROM THE FRAYED APRO AND IS IN CRITICAL CONDITION AT THIS TIME.