Description of Event or Problem · 1
ON MAY 20TH, 1992 SURGEON PERFORMED AN EP ABLATION PROCEDURE WITH A MANSFIELD EP SPECIAL POLARIS CATHETER. ABLATION WAS PERFORMED WITH AN AVERAGE OF 10 TO 30 DISCHARGES LASTING 20 TO 30 SECONDS EACH TIME USING BETWEEN 20 AND 30 WATTS RMS. THE MAJORITY WERE IN THE RANGE OF 20 TO 30 WATTS RMS. THE CATHETER WAS TESTED PRIOR TO USE. THE GENERATOR USED DURING THE PROCEDURE WAS AN ASPEN LABS EXCALIBUR. A VOLTIMETER WAS USED FOR ASSISTANCE IN MEASURING IMPEDANCE LEVELS AND REGISTERED AN OPEN CIRCUIT BUT THE ASPEN UNIT INDICATED A CLOSED CIRCUIT. AFTER 32 ATTEMPTS BETWEEN 20 AND 30 WATSS RMS., THEY INCREASED THE POWER TO 40 WATTS RMS WITH A FREQUENCY OF 417 KHZ LASTING LESS THAN 5 SECONDS. THE PATIENT COMPLAINED OF PAIN, HAD A FATAL ARRYTHMIA AND EXPIRED IN 30 MINUTES. IT WAS REPORTED THAT THIS CATHETER HAD BEEN USED MORE THAN 7 TIMES AND POSSIBLY UP TO 12 TIMES. THE CATHETER IS NOT FDA APPROVED FOR ABLATION AND THE LABEL STATES THAT IT IS AN ELECTROPHYSIOLOGY CATHETER AND FOR SINGLE USE ONLYDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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 NOT USED AS LABELED/INDENDED.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: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.