Description of Event or Problem · 1
PT HAS UNDERGONE A PERIPHERAL INTERVENTIONAL PROCEDURE UTILIZING THE CSI DIAMOND BACK ROTATIONAL ATHERECTOMY DEVICE WITH A COMPANY REPRESENTATIVE IN THE CARDIAC CATH LAB HERE AT (B)(6) MEDICAL CENTER, (B)(6). THE DEVICE ROTATES AT 3 DIFFERENT PRESET RPM LEVELS. AS THE RPM LEVEL INCREASES, THE DEVICE IS SUPPOSED TO INCREASE LUMINAL DIAMETER. THE DEVICE PERFORMED ADEQUATELY AT LOW AND INTERMEDIATE RPM SETTINGS. HOWEVER, AT 120,000 RPM WHICH IS THE HIGHEST SETTING THERE WAS AN INSTANT MALFUNCTION. THE DIAMOND TIPPED DEVICE GLIDES ON A WIRE CALLED "VIPER WIRE". AT 120,000 RPM, WE NOTICED A WIRE FRAGMENT PARTIALLY IMBEDDED IN THE DESCENDING AORTIC WALL, MOVING WITH EACH PULSE. WE PROMPTLY SNARED AND CAPTURED THE FRAGMENT WHICH REQUIRED OBTAINING CONTRALATERAL ACCESS IN THE LEFT COMMON FEMORAL ARTERY. UPON VISUALIZATION OF THE WIRE FRAGMENT, IT APPEARS TO HAVE THE RADIO-OPAQUE WIRE TIP WITH ABOUT 9 INCHES OF UNRAVELED WIRE FILAMENT. AS THE TIP OF THE WIRE IS BRAIDED, IT APPEARS THAT WIRE HAS UNBRAIDED ITSELF AND FRACTURED. THIS IS A POTENTIAL HAZARD TO THE PT. THE BRAIDED FILAMENT WAS NOT ABLE TO BE VISUALIZED ON FLUOROSCOPY. IF THE DEVICE WAS USED AGAIN, THE FILAMENT WOULD HAVE ENTANGLED THE ROTATIONAL HEAD AND POSSIBLY CAUSING PT ARTERY DISSECTION/RUPTURE. THERE APPEARS TO BE A SERIOUS FLAW IN THIS DEVICE IS IT APPEARS TO BE UNSAFE IN ITS PRESENT STATE. RETRIEVAL OF FRACTURED WIRE TIP AND UNRAVELLED BRAIDED FILAMENT WITH ENSNARE RETRIEVAL DEVICE. ON (B)(6)2010. DATES OF USE: (B)(6)2010, 10 MINUTES. DIAGNOSIS OR REASON FOR USE: CALCIFIED LESION. EVENT ABATED AFTER USE: NO.