Description of Event or Problem · 0
THIS LETTER IS TO INFORM YOU OF RECEIPT OF INFORMATION ABOUT AN ADVERSE EVENT REGARDING A PRODUCT WHICH (B)(6) DID NOT MANUFACTURE OR IMPORT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMOPTYSIS DURING THE CARDIOMEMS IMPLANT PROCEDURE AND THAT THE PATIENT DIED. DURING PROCEDURE THE PHYSICIAN GAINED ACCESS AND PROCEEDED TO USE A MEDTRONIC 0.18 NITREX GUIDEWIRE. THE PHYSICIAN ADVANCED THE WIRE TO THE PULMONARY ARTERY. THE PHYSICIAN USED A SWAN GANZ CATHETER OVER THE WIRE. THE PATIENT COUGHED A FEW TIMES, BUT THE PHYSICIAN PROCEEDED WITH THE RIGHT HEART CATHETERIZATION. IT WAS THEN THAT THE PATIENT EXPERIENCED HEMOPTYSIS. THE PATIENT'S STATUS WAS DETERIORATING SO THE CODE TEAM WAS CALLED IN TO TRY TO RESUSCITATE THE PATIENT. THE PHYSICIAN DID A THORACOTOMY TO TRY TO STOP THE BLEEDING. THE PATIENT DIED IN THE CATH LAB. THE CARDIOMEMS SENSOR WAS NOT OPENED OR INSERTED INTO THE BODY. NO SPECIFIC CAUSE OF DEATH WAS LISTED IN THE PATIENT¿S CHART. THE PHYSICIAN BELIEVED THAT THERE MUST HAVE BEEN A PERFORATION, BUT ONE COULD NOT BE IDENTIFIED. REF REPORT: MW5158022. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).