Description of Event or Problem · 1
LIMITED INFO THAT GALIL MEDICAL LTD ("GALIL" OR "THE COMPANY") HAS RECEIVED TO DATE REGARDING THIS EVENT INDICATES THAT A PT DIED ON 12/2/98, DURING PERCUTANEOUS HEPATIC CRYOABLATION USING THE CO'S CRYO-HIT SYSTEM WITH A 3MM CRYOPROBE. ALTHOUGH THE EVENT OCCURRED ON 12/2/98, GALIL DID NOT LEARN OF THE EVENT UNTIL 4/19/99 WHEN IT RECEIVED A LETTER DATED 3/15/99 BASED ON THE HOSP REPORT DATED 2/22/99, 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 1/12/99 (COPIES ATTACHED). OTHER EVENT IS THE SUBJECT OF MDR MFR REPORT # 9616793-1999-0001. HOSP AT WHICH THE CRYOSURGERY WAS PERFORMED CONDUCTED AN INVESTIGATION OF THESE TWO INCIDENTS. NO AUTOPSY WAS DONE IN THE FIRST CASE. HOSP ALSO CONCLUDED THAT, EVEN IF THERE IS NOT ANY DIRECT EVIDENCE, AND IN THE ABSENCE OF EVIDENCE SUGGESTING OTHER CAUSES, DEATH WAS, IN ALL PROBABILITY, DUE TO AN AIR EMBOLISM. HOSP CONCLUDED THAT STRUCTURAL FAILURE OF THE INTEGRITY OF THE CRYOPROBE ALLOWED ESCAPE OF ARGON AND/OR HELIUM GAS INTO THE CIRCULATION. IN ADDITION, HOSP CONCLUDED THAT 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 CAUSES THE EVENT. (SEE USER MANUAL SECTION 5.3.2 (ATTACHMENT 1 TO THIS MDR). MOREOVER, HOSP CONCLUDED THAT AT LEAST 10 MINS PASSED BEFORE RESUSCITATIVE EFFORTS WERE STARTED BY THE ATTENDING ANESTHESIOLOGIST. DELAY SEEMED TO BE DUE IN THE DOCTORS OPINION TO FAILURE TO BELIEVE THE INSTRUMENTS USED TO MONITOR THE CARDIOVASCULAR STATUS OF THE PT AND THE RELATIVE INACCESSIBILITY OF THE PT WHEN IN THE CORE OF THE IMRI. GALIL BELIEVED, AT THAT TIME, THAT NO MDR WAS REQUIRED TO BE SUBMITTED TO FDA REGARDING THE 12/2/98 EVENT BECAUSE IT APPEARED THAT THE CRYOPROBE USED IN THAT EVENT WAS THE SAME PROBE AS THAT USED IN A SIMILAR INCIDENT ON 1/12/99. GALIL HAD ALREADY TENTATIVELY CONCLUDED THAT THE CO'S PRODUCTS HAD NOT CAUSED OR CONTRIBUTED TO THE 1/12/99 EVENT AND NO MDR WAS REQUIRED. FOLLOWING FURTHER DISCUSSIONS WITH FDA, GALIL DECIDED TO SUBMIT THE ENCLOSED TWO MDRS REGARDING EACH OF THE TWO EVENTS SO THAT FDA WOULD HAVE ALL OF THE INFO AVAILABLE TO THE CO. BASED ON DISCUSSIONS WITH FDA, GALIL HAS DECIDED TO SUBMIT THIS REPORT IN ORDER TO PROVIDE THE AGENCY WITH ALL OF THE INFO CO HAS ABOUT THIS EVENT. ANY ADD'L INFO REGARDING THE EVENT THAT GALIL OBTAINS FROM HOSP REGARDING THIS EVENT WILL BE SUBMITTED TO FDA IN A FOLLOW-UP REPORT. FDA SHOULD BE AWARE THAT OVER 250 PROCEDURES HAVE BEEN PERFORMED WITHOUT ONE REPORTED INJURY OR ADVESE 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 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.