MERIT CUSTOM KIT

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS CORONARY INTERVENTION [PCI], AIR WAS INTRODUCED INTO THE PATIENT VASCULATURE SYSTEM. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S ASCENDING AORTA UNDER FLUOROSCOPY WITH A GUIDE CATHETER OVER A GUIDEWIRE, TO SUCCESSFULLY CANNULATE AND OPACIFY A NATIVE CORONARY ARTERY. DURING THE PROCEDURE, AIR WAS INTRODUCED FROM A LEAK IDENTIFIED AT THE CONNECTION BETWEEN THE HPF TUBING AND A CONNECTOR DURING POWER INJECTIONS. THE PATIENT'S BP DRASTICALLY DROPPED, AND THE PATIENT WENT INTO TEMPORARY CARDIOPULMONARY ARREST AND WAS RESUSCITATED BY CPR. A CODE WAS CALLED AND EMERGENT ACLS/BLS MEDICAL INTERVENTION WAS ACTIVATED ACCORDING TO HOSPITAL PROTOCOL. THE PATIENT WAS TRANSFERRED TO ICU AND THE NEXT DAY TRANSFERRED TO A STEPDOWN UNIT FOR RECOVERY. NO ADDITIONAL CONSEQUENCES TO REPORT.

Additional Manufacturer Narrative

THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND 2 SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. CORRECTIVE ACTIONS ARE IN PROCESS.