Description of Event or Problem · 1
A PATIENT WITH RIGHT FEMORAL VEIN THROMBOSIS WAS SCHEDULED FOR INSERTION OF GREENFIELD FILTER ON 10/22/93. THIS PROCEDURE WAS TERMINATED WHEN PHYSICIAN WAS UNABLE TO PASS FILTER THROUGH ILIAC VEIN BECAUSE OF THE ACUTE ANGLE. TWO DAYS LATER THE PATIENT AGAIN UNDERWENT SAME PROCEDURE. THE FILTER WAS INSERTED BUT REMAINED IN CLOSED POSITION. SUBSEQUENT VENA CAVOGRAM RESULTS CONFIRMED FILTER WAS NOT OPEN AND WAS NOT IN THE INFERIOR VENA CAVA. ON OCTOBER 26, 1993 A NEW GREENFIELD FILTER WAS PLACED WITHOUT COMPLICATION. THE EARLIER FILTER WAS NOT REMOVED BECAUSE OF THE RISK OF AN INFERIOR VENA CAVA WALL RUPTURE. PATIENT IS THUSFAR ASYMOTOMATIC.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.