BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDANT - GALILEO SYSTEM

    MDR report key: 414862 · Received August 30, 2002

    Report

    Report Number
    MW1026047
    Event Type
    Other
    Date Received
    August 30, 2002
    Date of Event
    August 29, 2002
    Report Date
    August 30, 2002
    Manufacturer
    GUIDANT CORP., VASCULAR INTERVENTION
    Product Code
    MOU
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/19/02: THE SITE SUCCESSFULLY TREATED A PT EARILER IN THE DAY AND POWERED THE SYSTEM DOWN. A NEW PT WAS BEING BROUGHT IN FOR TREATMENT. DURING THIS TIME, THE SYSTEM WAS POWERED ON BUT COULD NOT COMPLETE BOOT UP. SEVERAL ATTEMPTS WERE MADE TO REBOOT THE SYSTEM BUT THEY WERE ALL UNSUCCESSFUL. THE SYSTEM WOULD STOP ON A BLUE SCREEN AND THE FOLLOWING VERBIAGE WAS NOTED: SDU FILE OPEN FAILURE (FIELD1.IMG) ERROR READING HEAD FIELD NVM SDU FILE OPEN FAILURE (FIELD2.IMG) ERROR WRITING FIELD FLASH BACKUP VALID FOR RESTORE=FALSE ALL COPIES OF PARAMETERS CORRUPT. NO ATTEMPTS WERE MADE TO PERFORM THE TREATMENT, AS THE SYSTEM DID NOT BOOT UP. SOFTWARE ENGINEERING WAS CONSULTED AND THE DECISION WAS MADE TO REPLACE THE HEAD. UPON RECEIPT BY QUALITY ENGINEERING, THE HEAD WAS POWERED UP IN DIAGNOSTICS MODE AND THE REPORTED ERROR MESSAGES WERE GENERATED. HEAD NVM DATA (NON-VOLATILE MEMORY) IN THE CONFIGURATION FILES WERE REVIEWED; DATA FIELDS CONTAINING CYCLE COUNT AND PHYSICS AND TREATMENT MODE PASSWORDS WERE NOTED TO BE CORRUPT. ALL OTHER DATA IN THE CONFIGURATION FILES APPEARED TO BE NORMAL. THE CORRUPT DATA WAS RE-ENTERED INTO THE CONFIGURATION FILES AND THE SYSTEM WAS REBOOTED NUMEROUS TIMES WITH NO FURTHER ERRORS BEING GENERATED. THE UNIT WAS POWERED DOWN IN VARIOUS STAGES OF THE WIRE PARK SEQUENCE IN ORDER TO DUPLICATE THE REPORTED ERRORS. IT WAS DETERMINED THAT THE ERRORS COULD BE REPRODUCED BY POWERING THE SYSTEM OFF DURING A VERY NARROW TIME WINDOW OF THE PARK SEQUENCE WHILE THE SYSTEM IS WRITING TO THE HEAD NVM. ANALYSIS OF THE RETURNED HEAD DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ERRORS WAS MOST LIKELY DUE TO A LOSS OF POWER WHILE THE SYSTEM WAS WRITING POST-TREATMENT INFO TO THE HEAD NVM. THERE ARE TWO (2) HEAD CONFIGURATION FILES (ONE SERVES AS A BACKUP FILE) THAT STORE THE PASSWORDS, TOUCH SCREEN CALIBRATION, HEAD CYCLE COUNT, AND SERIAL NUMBER DATA. WHEN ONE FILE IS CORRUPTED AFTER BOOT UP, THE REMAINING CONFIGURATION FILE RESTORES THE BACKUP. IN THIS CASE, BOTH HEAD CONFIGURATION FILES WERE CORRUPTED. THE SOFTWARE IS WRITTEN TO ONLY OPEN AND CLOSE ONE FILE AT A TIME DURING UPDATES TO AVOID DUAL FILE CORRUPTION, HOWEVER, THE FLASH DISK (WHERE THE FILES RESIDE) IS NOT IMMEDIATELY WRITING THE FILES BUT IS CACHING THE DATA BRIEFLY. IF THE SYSTEM EXPERIENCES A POWER LOSS DURING THIS CACHING, IT IS POSSIBLE FOR BOTH FILES TO BE LOST OR CORRUPTED. THE POWER LOSS IS BELIEVED TO BE A RESULT OF THE USER POWERING DOWN THE SYSTEM AFTER THE INACTIVE OR ACTIVE WIRE HAD BEEN RETRACTED BUT BEFORE THE WIRE HAD COMPLETED ITS PARK SEQUENCE. PER THE IFU AFTER COMPLETING A TREATMENT, THE USER IS INSTRUCTED TO RECORD INFO IN THE TREATMENT SUMMARY SCREEN AND TURN OFF THE SYSTEM AFTER RETURNING TO THE MAIN SCREEN. IF THESE STEPS ARE TAKEN, THE SYSTEM WILL CORRECTLY WRITE FIELDS TO THE NVM. IN RESPONSE TO THIS EVENT, A TECHNICAL BULLETIN WAS SENT TO THE GUIDANT FIELD REPS FOR COMMUNICATION TO THE SITES THAT THE SYSTEM SHOULD BE ALLOWED TO RETURN TO THE MAIN SCREEN PRIOR TO POWERING DOWN AFTER PERFORMING A TREATMENT. ADDITIONALLY, A SUBSEQUENT REVISION OF SOFTWARE WILL BE MODIFIED TO MINIMIZE THE OCCURRENCE OF DUAL FILE CORRUPTION.

    Description of Event or Problem · 1

    THE OTHER DAY WHILE IN THE CARDIAC CATH LAB A NEW MEDICAL DEVICE MFG BY GUIDANT - CALLED THE GALILEO SYSTEM FOR INTRAVASCULAR BRACHYTHERAPY FAILED TO BOOT-UP THE REGULAR PROGRAM. THE ON SCREEN ERROR MESSAGE DID NOT ALLOW USER TO CONTINUE WITH SCHEDULED PROCEDURES. A CALL WAS PLACED WITH THE GUIDANT SVC REP AND USER IS FOLLOWING UP WITH GUIDANT RE: CORRECTIVE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT - GALILEO SYSTEM INTRAVASCULAR BRACHYTHERAPY (P-32 SOURCE) MOU GUIDANT CORP., VASCULAR INTERVENTION GUIDANT GALILEO *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other SINGLE UNIT AT SITE.