PERICARDIOCENTESIS KIT

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

THE ACCOUNT ALLEGES THAT AT THE END OF A CRYOTHERAPY PROCEDURE FOR ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION, THE PATIENT WAS UNRESPONSIVE TO SIMPLE COMMANDS. THE CLINICAL TEAM SUSPECTED CARDIAC TAMPONADE. CPR WAS ADMINISTERED AND THE PATIENT WAS INTUBATED. TWO ATTEMPTS TO PERFORM A PERICARDIOCENTESIS WERE ATTEMPTED BY THE ATTENDING PHYSICIAN. FIRST ATTEMPT: PERICARDIAL PUNCTURE IS UNSUCCESSFULLY ATTEMPTED WITH THE 18G PINK NEEDLE. THE PRACTITIONER STATES THAT THE NEEDLE MAY BE CLOGGED; IT WAS IMPOSSIBLE TO PULL BACK ON THE PLUNGER OF THE SYRINGE. SECOND ATTEMPT: PERICARDIAL PUNCTURE IS ATTEMPTED WITH A PINK SPINOCAN 18GG 88MM NEEDLE REFERENCE 4501390 FROM BBRAUN. THIS ATTEMPT WAS SUCCESSFUL, AND THE PROCEDURE WAS COMPLETED WITH 90 ML'S OF BLOOD REMOVED FROM THE PATIENT'S PERICARDIAL SACK. THE SAME SYRINGE WAS USED WITH BOTH NEEDLES. THE PATIENT'S VITAL SIGNS IMPROVED.