AN EVENT OCCURRED THAT WAS REPORTED AS A PERFORATION AT THE OSTIUM OF THE DIAGONAL BRANCH IN A CASE WHERE GLIDER PTCA AND SEVERAL OTHER MEDICAL DEVICES WERE USED. THERE WAS SOME RESISTANCE FELT DURING CROSSING TO THE DIAGONAL BRANCH. THE GLIDER DEVICE WAS INFLATED TWICE. THE FIRST INFLATION OF THE GLIDER WAS AT THE OSTIUM OF THE DIAGONAL TO 4 ATMOSPHERES. A SUBSEQUENT ANGIOGRAM REVEALED AN ABNORMAL APPEARANCE TO THE PROXIMAL DIAGONAL. LATER REVIEW OF THE ANGIO DETERMINED THAT THERE WAS A PERFORATION AT THAT POINT. THE GLIDER WAS THEN ADVANCED SLIGHTLY AND RE-INFLATED TO NOMINAL PRESSURE. THE SUBSEQUENT ANGIOGRAM REVEALED A VERY LARGE FREE-FLOWING PERFORATION IN THE VICINITY OF THE PROXIMAL/OSTIAL DIAGONAL. THE EMERGENCY PERICARDIOCENTESIS FOLLOWED, A COVERED STENT WAS PLACED. THE PT DEVELOPED CARDIOGENIC SHOCK AND ULTIMATELY EXPIRED.
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Patient 1
INSPECTION AND LOT HISTORY RECORDS FOR LOT FC120423003 AND THE SUBASSEMBLIES USED IN ITS MANUFACTURE WERE REVIEWED. NO OUT OF SPECIFICATION FINDINGS WERE OBSERVED. RETURN OF THE DEVICE WAS REQUESTED BUT THE DEVICE HAD BEEN DISPOSED. RELEVANT ANGIOGRAMS WERE REQUESTED BUT HAVE NOT YET ARRIVED. THE INTERNAL INVESTIGATION IS ON-GOING. A F/U MDR WILL BE FILED AFTER RECEIPT AND REVIEW OF THE ANGIOGRAMS AND COMPLETION OF THE INTERNAL INVESTIGATION.