BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3165522 · Received June 12, 2013

    Report

    Report Number
    2950727-2013-00018
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Report Date
    June 12, 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 FIBER OPTIC PORTION OF THE SOLOGRIP III HANDPIECE WAS NOT ABLE TO ADVANCE THROUGH THE MYOCARDIUM AND EVENTUALLY STARTED SMOKING. THE HANDPIECE WAS NOT RETAINED FOR INVESTIGATION. THE LOT NUMBER AND SERIAL NUMBER OF THE DEVICE IN QUESTION WERE NOT PROVIDED. THUS, THREE POSSIBLE LOT NUMBERS WERE IDENTIFIED BASED ON SHIPPING RECORDS. NO ISSUES WERE DOCUMENTED DURING THE BUILD OF THESE LOTS. ALTHOUGH THE CAUSE OF THE REPORTED MALFUNCTION COULD NOT BE DETERMINED, IT IS POSSIBLE THAT THE ROOT CAUSE IS IMPROPER HANDLING OF THE OPTICAL 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 THE MALFUNCTION WAS CONFINED TO THE HANDPIECE HOUSING WHICH DOES NOT CONTACT THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE FIBER OPTIC PORTION OF THE HANDPIECE WAS NOT ABLE TO ADVANCE THROUGH THE MYOCARDIUM AND EVENTUALLY IT STARTED SMOKING. THE HANDPIECE WAS NOT RETAINED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265516 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION 705-37020

    Patients

    Seq Age Sex Outcome Treatment
    1