TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Description of Event or Problem

AS REPORTED, 30 MINUTES AFTER THE START OF A PERCUTANEOUS CORONARY INTERVENTION IN THE CARDIAC CATHETERIZATION LABORATORY IN A 75-YEAR-OLD MALE WITH MYOCARDIAL INFARCTION DUE TO ACUTE CORONARY HEART DISEASE, FOUR BUBBLES WERE OBSERVED IN THE BLOOD VESSELS WHILE THE PATIENT WENT INTO CARDIAC ARREST AND DIED AFTER RESUSCITATION EFFORTS FAILED. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL 5 DAYS EARLIER DUE TO THE WORSENING OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) DISEASE. DURING THE OPERATION, THE PATIENT CORONARY ANGIOGRAPHY REVEALED THE PRESENCE OF AIR BUBBLES. HOWEVER, NO ABNORMALITIES WERE IDENTIFIED AFTER INSPECTION OF THE DPT (DISPOSABLE PRESSURE TRANSDUCER) AND OTHER CONNECTED DEVICES. APPROXIMATELY 30 MINUTES AFTER THE START OF THE PROCEDURE, AIR BUBBLES WERE AGAIN OBSERVED IN THE PATIENT CORONARY ARTERY, ACCOMPANIED BY A DECREASE IN HEART RATE AND A DROP IN BLOOD PRESSURE. UPON PRELIMINARY INSPECTION, THE MALE LUER LOCK OF THE DPT THAT CONNECTS TO THE CATHETER WAS FOUND TO BE DEFORMED. THIS DEFORMATION MAY HAVE BEEN A POTENTIAL SOURCE OF AIR LEAKAGE. THE INVESTIGATION IS STILL ONGOING AT THE SITE.

Additional Manufacturer Narrative

THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS, BUT IT HAS NOT BEEN NOT EVALUATED YET. UPON THE EVALUATION OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.