RIPTIDE ASPIRATION SYSTEM REACT 68 CATHETER

Additional Manufacturer Narrative

THE REACT CATHETER WAS RETURNED FOR ANALYSIS. THE CATHETER¿S MARKER BAND WITH DISTAL TIP WERE OBSERVED TO BE MISSING. THE CATHETER OUTER PEBAX TUBING AND INNER PTFE TUBING/LINER WERE FOUND TO BE TORN WITH THE INNER NITINOL COIL STRETCHED. THE INNER BRAID APPEARED TO BE INTACT. THE CATHETER OUTER PEBAX TUBING AND INNER PTFE TUBING/LINER END EXHIBITED STRETCHING AND JAGGED EDGES. BASED ON THE INVESTIGATION AND EVALUATION, THE REPORT OF REACT CATHETER TIP SEPARATION WAS CONFIRMED. THE MOST PROBABLE CAUSE OF THE REACT CATHETER TIP SEPARATION WAS INCREASED RESISTANCE DURING WITHDRAWAL OF THE REACT CATHETER DUE TO A BENT SHEATH. PLASTIC DEFORMATION (STRETCHING AND JAGGED EDGES) OF THE REACT CATHETER BROKEN END AND THE STRETCHING OF THE INNER NITINOL COIL INDICATE THAT THE TIP SEPARATED WHEN THE TENSILE STRENGTH OF THE CATHETER WAS EXCEEDED. THE REACT CATHETER INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING PRECAUTION, ¿DO NOT ADVANCE OR WITHDRAW THE CATHETER AGAINST RESISTANCE WITHOUT CAREFUL ASSESSMENT OF THE CAUSE USING FLUOROSCOPY. IF THE CAUSE CANNOT BE DETERMINED, WITHDRAW THE DEVICE. MOVING OR TORQUEING THE DEVICE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE VESSEL OR DEVICE.¿ IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

MEDTRONIC RECEIVED REPORT OF REACT CATHETER TIP SEPARATION DURING A PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, A SHEATH WAS DELIVERED TO THE PROXIMAL INTERNAL CAROTID ARTERY (ICA) AND THE REACT CATHETER WAS DELIVERED TO THE M1. ASPIRATION OF THE CLOT INTO THE REACT CATHETER WAS PERFORMED, THEN THE REACT CATHETER WAS ATTEMPTED TO BE PULLED FROM THE PATIENT. HOWEVER, ON REMOVAL, THE REACT CATHETER MET RESISTANCE IN THE SHEATH AND COULD NOT BE REMOVED. IT WAS REPORTED THAT THIS OCCURRED IN A VERY KINKED PROXIMAL SEGMENT OF THE ICA. THE SHEATH WAS NOTED TO CRINKLE IN ITS DISTAL SEGMENT. THE REACT CATHETER WAS AGAIN PULLED; RESISTANCE WAS EXPERIENCED AT WHICH POINT THE REACT CATHETER TIP ¿BROKE OFF.¿ THE REACT CATHETER WAS REMOVED. A RUN WAS PERFORMED, WHICH SHOWED THAT THE TIP OF THE REACT CATHETER HAD ADVANCED TO THE M1. MULTIPLE ATTEMPTS TO RETRIEVE THE REACT CATHETER TIP USING ASPIRATION AND STENTS WERE NOT SUCCESSFUL. IT WAS REPORTED THAT THE REACT CATHETER TIP ADVANCED TO THE M4 AND REMAINS IN THE PATIENT. THE PATIENT IS REPORTEDLY DOING WELL. PRE-PROCEDURE, THE PATIENT'S NIHSS WAS 14. THE FOLLOWING MORNING, THE PATIENT'S NIHSS WAS 6. THE PATIENT WAS REPORTED TO BE DOING WELL.