PHD¿

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE IDENTIFIED. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND.

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS NOT 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 THE PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE PATIENT, THERE WERE COMPLAINTS OF THE HEMOSTASIS VALVE SPRING MECHANISM NOT GOING BACK TO ITS DEFAULT POSITION WHEN PUSHED. SUBSEQUENTLY, PATIENT HAD ST ELEVATION AND HAD CARDIAC ARREST. PATIENT HAD ROSC AND HAD FULL RECOVERY AND WAS DISCHARGED FROM THE HOSPITAL TWO DAYS LATER.