Description of Event or Problem · 1
SAME CASE AS MFR. REPORT #'S: - 2134265-2008-02429 AND 2134265-2008-02430. IT WAS REPORTED THAT DURING AN ATTEMPTED ROTATIONAL ATHERECTOMY OF THE PROXIMAL RIGHT CORONARY ARTERY, A DISSECTION, PERFORATION AND FRACTURE OF THE GUIDE WIRE OCCURRED. DURING A DIAGNOSTIC PROCEDURE, THE PATIENT WAS FOUND TO HAVE SINGLE VESSEL DISEASE WITH A VERY CALCIFIED, COMPLEX LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AS WELL AS A 60 - 70 % STENOSIS IN THE DISTAL RCA. THE PHYSICIAN WIRED THE LESION WITH A PT GRAPHIX GUIDE WIRE AND ATTEMPTED TO CROSS THE LESION WITH TWO CUTTING BALLOONS, HOWEVER, THIS WAS UNSUCCESSFUL. THEREFORE, A DECISION WAS MADE TO PERFORM ROTATIONAL ATHERECTOMY. THE GUIDE CATHETER WAS EXCHANGED FOR AN 8F JR4 WITH SIDE HOLES AND THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH THE ROTAWIRE FLOPPY GUIDE WIRE. THIS WAS NOT SUCCESSFUL. THE LESION WAS THEN CROSSED WITH A LONG PT GRAPHIX GUIDE WIRE, AND AN ATTEMPT TO EXCHANGE IT USING ANOTHER MANUFACTURERS CATHETER WAS UNSUCCESSFUL, AS THE CATHETER WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN WAS FINALLY ABLE TO CROSS THE LESION USING AN UNSPECIFIED OVER THE WIRE BALLOON AND THE ROTAWIRE FLOPPY GUIDE WAS PASSED THROUGH THE LUMEN OF THE BALLOON AND POSITIONED DISTALLY INTO THE ARTERY. ROTATIONAL ATHERECTOMY WITH A 1.25 BURR WAS THEN CARRIED OUT. THE TECHNIQUE WAS ONE OF APPROACHING THE LESION, PECKING AT IT FOR A FEW SECONDS, WITHDRAWING AND DOING NO MORE THAN TEN TO FIFTEEN SECONDS APPLICATIONS AT A TIME. THE PHYSICIAN MADE GRADUAL PROGRESS THROUGH THE LESION AND TOWARDS THE END, ONCE THE BURR CLEARED THE LESION ON THE LEFT APPLICATION, THE BURR STALLED. THE PHYSICIAN WAS ABLE TO PULL THE BURR BACK WITHOUT SIGNIFICANT DIFFICULTY. AT THAT POINT, INJECTION OF CONTRAST DEMONSTRATED THAT THE ARTERY HAD DISSECTED. THERE WAS EXTRAVASATION OF CONTRAST INTO THE PERICARDIUM. THE BURR WAS THEN REMOVED USING STANDARD PROCEDURE AND IT WAS NOTED THAT THE WIRE WAS LEFT IN THE CORONARY ARTERY. AT SOME POINT DURING THE PROCEDURE, THE WIRE HAD BECOME CUT. THE PHYSICIAN THEN ATTEMPTED TO WIRE THE RCA WITH A PT GRAPHIX GUIDE WIRE, HOWEVER, THIS WAS UNSUCCESSFUL. THE PATIENT EXPERIENCED SIGNIFICANT ST ELEVATIONS AND PAIN WHICH WAS TREATED WITH DILAUDID. THE PATIENT WAS THEN TAKEN FOR EMERGENT CORONARY ARTERY BYPASS GRAFT SURGERY. THE PATIENT LEFT THE CATH LAB IN RELATIVELY STABLE CONDITION, HOWEVER, AND ELECTROCARDIOGRAM SHOWED SIGNIFICANT ST ELEVATIONS AND THE ARTERY COMPLETELY CLOSED. PATIENT STATUS POST SURGERY WAS SATISFACTORY.