Description of Event or Problem · 1
ON JANUARY 19, 1999, GALIL MEDICAL LTD. ("GALIL" OR "THE CO") WAS INFORMED BY THE HOSP THAT A TERMINALLY ILL PT DIED ON JANUARY 12, 1999 DURING PERCUTANEOUS HEPATIC CRYOABLATION USING THE CO'S CRYO-HIT SYSTEM WITH A 3MM CRYOPROBE. A GALIL REP VISITED THE HOSP ON JANUARY 22, 1999, AND LEARNED THAT THE PT WAS TERMINALLY ILL WITH A LIFE EXPECTANCY OF TWO WEEKS. THE PT DIED TOWARDS THE END OF THE PROCEDURE, AND NO SIGNS OF MALFUNCTION OF THE CRYO-HIT SYSTEM OR THE 3MM CRYOPROBE WERE OBSERVED BY THE PHYSICIAN AND STAFF DURING THE PROCEDURE. AN AUTOPSY WAS PERFORMED AND NO CAUSE OF DEATH WAS DETERMINED. THE CRYOSURGICAL EQUIPMENT WAS FIRST CHECKED BY THE HOSP STAFF ON JANUARY 15, 1999. AT THAT TIME, THE STAFF DETERMINED THAT THERE WAS A GAS LEAK IN THE 3MM CRYOPROBE USED IN THE PROCEDURE. WHEN THAT PROBE WAS CHECKED BY A GALIL REP ON JANUARY 22, 1999, HE OBSERVED THAT THE PROBE WAS SEVERELY DAMAGED, WHICH COULD EXPLAIN THE LEAKAGE. IT IS UNLIKELY THAT THE PROBE WOULD HAVE BEEN USED IN THE CRYOSURGICAL PROCEDURE ON THE DATE OF THE EVENT (I.E., JANUARY 12, 1999) IF IT HAD BEEN DAMAGED TO THE EXTENT NOTED BY THE GALIL REP ON JANUARY 22, 1999. IN THE INSTRUCTIONS GALIL GIVES TO THE USERS (TRAINING OR USER MANUAL) IT CLEARLY STATES NOT TO USE A DFECTIVE PROBE, AND TO SEND IT BACK TO GALIL MEDICAL. SO IT IS SENSIBLE TO THINK THAT THE PROBE MAY HAVE BEEN DAMAGED AFTER THE SURGICAL PROCEDURE DUE TO MISHANDLING DURING CLEANING OR TESTING. ON FEBRUARY 15, 1999, GALIL, BASED ON THE VERY PRELIMINARY INFO THE CO HAD ABOUT THIS EVENT, DICTATED A MEMORANDUM TO FILE EXPLAINING WHY THE CO CONCLUDED THAT THE EVENT WAS NOT DEVICE RELATED AND CONCLUDING THAT A MEDICAL DEVICE REPORT ("MDR") FROM THE CO WAS NOT WARRANTED (SEE ATTACHED). BASED ON SUBSEQUENT CONVERSATIONS WITH FDA, GALIL HAS DECIDED TO SUBMIT THIS MDR IN ORDER TO PROVIDE THE AGENCY WITH ALL OF THE INFO THE CO HAS ABOUT THIS EVENT. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY GALIL MEDICAL LTD THAT THE CO'S DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. ON APRIL 19, 1999, GALIL REC'D A LETTER DATED MARCH 15, 1999 BASED ON THE HOSP REPORT DATED FEBRUARY 22, 1999, FROM THE PHYSICIAN WHO PERFORMED THE PROCEDURE, TOGETHER WITH A COPY OF PART OF THE REPORT OF THE HOSP'S INVESTIGATION OF THIS EVENT AND A SIMILAR EVENT THAT OCCURRED ON DECEMBER 2, 1998 (COPIES ATTACHED). THE OTHER EVENT IS THE SUBJECT OF MDR MFR REPORT #9616793-1999-0002. GALIL BELIEVES THAT THE SAME REUSABLE 3MM CRYOPROBE WAS USED IN BOTH SURGICAL PROCEDURES. THE HOSP'S INVESTIGATION OF THOSE TWO INCIDENTS CONCLUDED THAT, EVEN IF THERE IS NOT ANY DIRECT EVIDENCE, AND IN THE ABSENCE OF EVIDENCE SUGGESTING OTHER CAUSES, DEATH WAS, IN ALL PROBABILITY, AIR EMBOLISM. THE HOSP CONCLUDED THAT STRUCTURAL FAILURE OF THE INTEGRITY OF THE CRYOPROBE ALLOWED ESCAPE OF ARGON AND/OR HELIUM GAS INTO THE CIRCULATION. IN ADDITION, THE HOSP CONCLUDED THAT THE FAILURE OF THE PHYSICIAN AND STAFF TO FOLLOW THE PRECAUTIONS IN THE MFR'S INSTRUCTIONS FOR USE MANUAL WITH REGARD TO TESTING THE PROBE PRIOR TO USE CAUSED THE EVENT. THE PREOPERATIVE PROCEDURES SET OUT IN THE DEVICE'S INSTRUCTION FOR USE MANUAL SPECIFY THAT THE CRYOPROBE IS TO BE TESTED FOR GAS LEAKAGE USING GAS PRIOR TO USE. (SEE USER MANUAL SECTION 5.3.2 (ATTACHMENT 1 TO THIS MDR). MOREOVER, GALIL HAS LEARNED THAT A 3MM CRYOPROBE WAS USED DURING THE PROCEDURE TO TREAT A 6CM AND AN 8CM LESION. THEREFORE, THE PROBE WAS USED TO TREAT LESIONS THAT WERE 20 AND MORE THAN 25 TIMES LARGER THAN AREA EXPECTED TO BE TREATED USING A 3MM PROBE. GALIL ALSO HAS LEARNED THAT THE 3MM CRYOPROBE WAS USED TO FREEZE THE LESIONS FOR APPROX 50 MINUTES. THE RECOMMENDED FREEZE TIME FOR CRYOSURGERY IN THE PUBLISHED LITERATURE IS 15 MINUTES. THUS, THE DURATION OF THE PROCEDURE WAS MORE THAN THREE TIMES THE RECOMMENDED DURATION. THUS, A VERY AGGRESSIVE TREATMENT WAS PERFORMED ON A TERMINALLY ILL PT WITH A VERY SHORT LIFE EXPECTANCY. FINALLY, TO PUT THESE METTERS IN PERSPECTIVE, FDA SHOULD BE AWARE THAT OVER 250 PROCEDURES HAVE BEEN PERFORMED WITHOUT ONE REPORTED INJURY OR ADVERSE EVENT. WHILE GALIL BELIEVES THAT THESE EVENTS ARE IN NO WAY RELATED TO A PROBE LEAKAGE, IF THERE IS SOME RELATIONSHIP BETWEEN THE PROBES AND THE DEATHS, IT IS LARGELY DUE TO THE FAILURE OF THE PHYSICIAN TO FOLLOW THE APPROPRIATE INSTRUCTIONS FOR USE. GALIL WILL BE FOLLOWING UP FURTHER WITH THE HOSP TO GATHER ALL APPLICABLE DATA ON THESE DEATHS, AND SUPPLEMENTAL INFO WILL BE FILED WITH FDA, AS APPROPRIATE.