OUTBACK RE-ENTRY CATHETER

Additional Manufacturer Narrative

PLEASE NOTE THAT THE GENDER OF THE PATIENT IS UNKNOWN. PLEASE NOTE THAT THE DATE OF THE EVENT IS UNKNOWN. COMPLAINT CONCLUSION: IT WAS REPORTED TO THE SALES REP BY THE CATHETERIZATION LAB THAT THEY HAD THREE OUTBACK CATHETERS THAT THE NEEDLE DID NOT DEPLOY DURING PREP DURING THE SAME PROCEDURE. A NON-CORDIS DEVICE WAS USED TO COMPLETE THE PROCEDURE. TWO UNITS ARE TO BE RETURNED, THE THIRD WAS THROWN AWAY. THE INTENDED PROCEDURE IS UNKNOWN; HOWEVER, IT WAS TREATMENT OF A CTO (CHRONIC TOTAL OCCLUSION) LESION. THERE WERE NO OTHER DAMAGES OR ANOMALIES NOTED TO THE DEVICE OR PACKAGING PRIOR TO USE. THE BOXES DID NOT LOOK DAMAGED PRIOR TO USE. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE IFU (INSTRUCTIONS FOR USE). THE DEVICE WAS NOT INSERTED INTO THE PATIENT. A NON-STERILE UNIT OF OUTBACK CTO CATHETER SYSTEMS WAS RETURNED. THE HANDLE SLIDE WAS RECEIVED IN PROXIMAL RETRACTION POSITION. PER VISUAL ANALYSIS NO DAMAGES WERE OBSERVED. PER DIMENSIONAL ANALYSIS THE CANNULA NEEDLE DEPLOYMENT LENGTH COULD NOT BE MEASURED AS THE NEEDLE COULD NOT BE DEPLOYED. PER MICROSCOPIC ANALYSIS THE NOSECONE TIP WAS TORN AT 1 CM FROM THE DISTAL TIP. PER FUNCTIONAL ANALYSIS THE UNIT WAS CLEANED WITH PEROXIDE AND BLOOD RESIDUALS WERE OBSERVED DURING THE FLUSHING. DURING SEVERAL ATTEMPTS OF CANNULA ACTUATION (DEPLOYMENT/RETRACTION), THE NOSECONE TIP WAS SEPARATED PARTIALLY AND NEEDLE WAS STUCK AT 2.5 CM FROM DISTAL TIP AND COULD NOT BE DEPLOYED. THE OUTBACK UNIT WAS RE-EXAMINED UNDER MICROSCOPE AND IT WAS NOTED THAT THE NOSECONE/KEY HOUSING UNION WAS DAMAGED. SINCE THE CANNULA COULD NOT BE DEPLOYED, THE SHAFT WAS CUT AND IT WAS OBSERVED UNDER MICROSCOPE THAT THE CANNULA NEEDLE TIP WAS BROKEN. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT 17257160 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿CTO CATHETER SYSTEM PREPPING DIFFICULTY-UNABLE TO DEPLOY NEEDLE¿ AND ¿CATHETER TIP/DISTAL TIP (OUTBACK ONLY) FRACTURED¿ WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED DURING ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, PROCEDURAL OR HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT AS EVIDENCED BY THE BROKEN NEEDLE TIP NOTED DURING ANALYSIS. ACCORDING TO THE IFU ¿USE STERILE TECHNIQUE TO CAREFULLY REMOVE THE OUTBACK LTD RE-ENTRY CATHETER (OB-LTD) FROM THE PACKAGING. INSPECT THE CATHETER FOR DAMAGE. AS PACKAGED, THE CANNULA TIP IS EXTENDED FROM THE OB-LTD LATERAL PORT AND A PLASTIC TUBE COVERS THE CANNULA TIP FOR PROTECTION. CAREFULLY REMOVE THIS PLASTIC TUBE BY HOLDING THE CURVED PORTION OF THE CANNULA WITH ONE HAND AND PULLING THE PLASTIC TUBE STRAIGHT AWAY FROM THE CANNULA TIP WITH THE OTHER HAND. FLUSH THE OB-LTD THOROUGHLY, AT THE FLUSH PORT AND THE GUIDE WIRE PORT, WITH STERILE HEPARINIZED SALINE UNTIL THE SOLUTION EXITS THE DISTAL END OF THE CATHETER. WAIT 30 SECONDS THEN FLUSH AGAIN. ENSURE PROPER FUNCTION OF THE OB-LTD BY 1) RETRACTING AND ADVANCING THE CANNULA TIP VIA PROXIMAL AND DISTAL MOVEMENT OF THE DEPLOYMENT SLIDE, AND 2) ROTATING THE ROTATING HEMOSTATIC VALVE (RHV), WHICH ROTATES THE CATHETER SHAFT/NOSECONE. FULLY RETRACT THE CANNULA TIP VIA PROXIMAL RETRACTION OF THE HANDLE DEPLOYMENT SLIDE UNTIL IT STOPS. PRIOR TO INSERTION INTO THE BODY, ENSURE THAT THE CANNULA TIP IS FULLY RETRACTED INTO THE CATHETER LATERAL PORT AND THE HANDLE DEPLOYMENT SLIDE IS LOCKED IN THE MOST PROXIMAL POSITION. IF NOT, REPEAT FLUSHING SEQUENCE AS DEFINED IN ¿3¿ ABOVE.¿ NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE EVENTS EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN.

Description of Event or Problem

IT WAS REPORTED TO THE SALES REP BY THE CATHETERIZATION LAB THAT THEY HAD THREE OUTBACK CATHETERS, ITEM OTB42120, THAT THE NEEDLE DID NOT DEPLOY DURING PREP DURING THE SAME PROCEDURE. A NON-CORDIS DEVICE WAS USED TO COMPLETE THE PROCEDURE. TWO UNITS ARE TO BE RETURNED, THE THIRD WAS THROWN AWAY. THE INTENDED PROCEDURE WAS UNKNOWN, HOWEVER, IT WAS TREATMENT OF A CTO LESION. THERE WERE NO OTHER DAMAGES OR ANOMALIES NOTED TO THE DEVICE OR PACKAGING PRIOR TO USE. THE BOXES DID NOT LOOK DAMAGED PRIOR TO USE. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE IFU. THE DEVICE WAS NOT INSERTED INTO THE PATIENT. ADDENDUM 04/28/2016: DURING PRODUCT ANALYSIS, THE OUTBACK WITH LOT 17257160 WAS INSPECTED UNDER VISION SYSTEM AND NOSECONE TIP WAS RECEIVED TORN AT 1 CM FROM DISTAL TIP. DURING FUNCTIONAL ANALYSIS, THE TIP PARTIALLY SEPARATED.