12 FR COOK SHEATH

Description of Event or Problem

IT WAS REPORTED THAT DURING THE CARDIOMEMS IMPLANT, THE SENSOR REMAINED ATTACHED TO THE DELIVERY CATHETER AFTER DEPLOYMENT. THE PHYSICIAN WAITED THROUGH SEVERAL CARDIAC CYCLES AND INSTRUCTED THE PATIENT TO TAKE A FEW DEEP BREATHS, BUT THE SENSOR DID NOT RELEASE. A SWAN¿GANZ CATHETER WAS THEN ADVANCED IN ATTEMPT TO BUMP THE SENSOR FREE; HOWEVER, THE PHYSICIAN WAS UNABLE TO REPOSITION THE SWAN¿GANZ BACK INTO THE PULMONARY ARTERY. A GUIDEWIRE WAS THEN USED TO DISLODGE THE SENSOR. THE PATIENT THEN DEVELOPED COUGHING WITH HEMOPTYSIS. IMAGING CONFIRMED A VASCULAR PERFORATION, THOUGH THE INJURED VESSEL WAS NOT ONE ACCESSED DURING THE PROCEDURE. THE PERFORATION WAS SUCCESSFULLY TREATED WITH COIL EMBOLIZATION AND THE PATIENT WAS ADMITTED TO INTENSIVE CARE. IT WAS NOT CONFIRMED HOW THE VESSEL WAS PERFORATED. THE PATIENT WAS DISCHARGED ON (B)(6) 2026. A COOK 12F SHEATH WAS USED FOR THIS CASE. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".