HEMEDEX QFLOW 500 PROBE

Description of Event or Problem

BACKGROUND: A MALE PATIENT AGED (B)(6) WITH TRAUMATIC BRAIN INJURY REQUIRED EMERGENCY LEFT FRONTOPARIETAL DECOMPRESSIVE CRANIOTOMY ((B)(6) 2009), IN WHICH A LARGE CRANIOTOMY WAS CARRIED OUT, THE BONE FLAP WAS NOT REPLACED AND THE DURA WAS LEFT OPEN. FOUR MONITORING DEVICES WERE INSERTED DURING THE PROCEDURE. ADVERSE EVENT ((B)(6) 2009: 11.00 PM) MICRODIALYSIS AND ICP CATHETERS WERE REMOVED UNEVENTFULLY. HOWEVER, EXTRA TRACTION HAD TO BE APPLIED TO THE HEMEDEX CATHETER, WHICH WAS SEEN TO BE MISSING ITS DISTAL PORTION (LENGTH UNDETERMINED AT THIS STAGE) ON REMOVAL. WHEN THE ADTECH STRIP WAS REMOVED, IT WAS SEEN TO BE PARTIALLY TRANSACTED AT THE BASE OF THE FLANGED PART OF THE STRIP, AND ONE PLATINUM CONTACT WAS MISSING. THE ADTECH STRIP AND MICRODIALYSIS CATHETER WERE RETAINED, BUT NOT THE ICP PROBE OR HEMEDEX PROBE. CT SCAN SHOWED THE REMAINING PORTION OF THE HEMEDEX PROBE IN THE SUBGALEAL PLANE, ENTIRELY OUTSIDE AND POSTERIOR TO THE CRANIOTOMY MARGIN, AND HENCE SOME 2 CM FROM THE NEAREST BRAIN TISSUE.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE USER FACILITY DID HOWEVER MAKE CONCLUSIONS AS TO THE CAUSE OF THE FAILURE. THEIR CONCLUSIONS WERE THAT HEMEDEX AND ECOG LEADS BECAME CROSSED DURING REMOVAL, THE HEMEDEX LEAD PARTIALLY DIVIDING THE ECOG CONNECTION AT THE BASE OF THE FLANGE, AND ITSELF BECAME SEVERED AT THIS POINT BY ENTRAPMENT IN THE ECOG STRIP FLANGE. THIS IS THE FIRST SUCH INCIDENT AT THE USER FACILITY, IN AN EXPERIENCE OF SOME 80 CASES IN WHICH ONE OR MORE MICRODIALYSIS/LICOX/ICP/HEMEDEX PROBES HAVE BEEN PLACED NEAR AN ADTECH ECOG STRIP. RECORDS AT HEMEDEX SHOW THAT IN OVER 3,500 USES OF THE PROBE, NO EVENTS SIMILAR TO THIS HAVE BEEN REPORTED. EVALUATION CONCLUDES THIS TO BE AN ISOLATED EVENT ATTRIBUTED TO USER HANDLING.