BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3165275 · Received June 12, 2013

    Report

    Report Number
    2950727-2013-00007
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    December 19, 2012
    Report Date
    June 4, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE SURGEON WAS ON HIS 5TH CHANNEL WITH THE SOLOGRIP III HANDPIECE WHEN THE FIBER FAILED TO GO THROUGH THE MYOCARDIUM. ANOTHER HANDPIECE WAS USED AND IT REPORTEDLY FAILED AFTER 4 CHANNELS WERE CREATED. NO ONE WAS INJURED AND THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT REPRESENTS THE FIRST OF THE TWO HANDPIECES. THE HANDPIECES WERE NOT RETURNED AND SERIAL NUMBERS WERE NOT PROVIDED. A MANUFACTURING RECORDS REVIEW OF POSSIBLE UNITS USED IN THE SURGERY WAS PERFORMED TO DETERMINE IF THERE WERE ISSUES DURING MANUFACTURING THAT COULD BE ATTRIBUTED TO THE REPORTED EVENT. THERE WERE NO ISSUES DURING MANUFACTURING NOTED IN THE DEVICE HISTORY RECORD FOR ANY OF THE LOTS POSSIBLY AVAILABLE AT THE TIME OF SURGERY. SINCE THE DEVICES WERE NOT RETURNED, AN EVALUATION OF THE HANDPIECES COULD NOT BE PERFORMED. THE CAUSE OF THE DAMAGE REPORTED IS MOST LIKELY FROM BENDING THE STRAIN RELIEF TUBING WHILE MOVING THE THUMBSLIDE, RESULTING IN RESTRICTION OF THE FIBER AND BUCKLING OF THE FIBER WITHIN IN THE HANDPIECE. WHEN THE LASER IS PULSED EXTREME HEAT IS PRODUCED RESULTING IN CHARRING OF THE FIBER. AS A CORRECTIVE ACTION, AN ATTENTION LABEL IS NOW ADHERED TO THE DEVICE PACKAGING. THE LABEL PROVIDES ADDITIONAL HANDLING INSTRUCTION DESIGNED TO PREVENT A RECURRENCE OF THIS TYPE OF EVENT. AT THE TIME THE REPORT WAS RECEIVED, CARDIOGENESIS DID NOT BELIEVE THE EVENT MET THE REPORTING REQUIREMENTS OF 21 CFR 803. THE EVENT DID NOT INVOLVE INJURY TO THE PATIENT, USER, OR ANY OTHER INDIVIDUAL. FURTHERMORE, THE EVENT WAS CONSIDERED TO BE OF A NATURE SUCH THAT A RECURRENCE COULD NOT REASONABLY BE EXPECTED TO CAUSE INJURY OR DEATH BECAUSE NO POTENTIALLY HARMFUL CONDITIONS WERE REPORTED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SURGEON WAS ON HIS 5TH CHANNEL WITH THE SOLOGRIP III HANDPIECE WHEN THE FIBER FAILED TO GO THROUGH THE MYOCARDIUM. ANOTHER HANDPIECE WAS USED AND IT REPORTEDLY FAILED AFTER 4 CHANNELS WERE CREATED. NO ONE WAS INJURED AND THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT REPRESENTS THE FIRST OF THE TWO HANDPIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266473 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3

    Patients

    Seq Age Sex Outcome Treatment
    1