BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BP2 ABLATION DEVICE

    MDR report key: 1658642 · Received April 7, 2010

    Report

    Report Number
    2135394-2010-00007
    Event Type
    Injury
    Date Received
    April 7, 2010
    Report Date
    March 19, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    OCL
    PMA / PMN Number
    K080509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT AVAILABLE. RESULTS: DEVICE HISTORY COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT AVAILABLE AND NO PRODUCT WAS RETURNED FOR ANALYSIS. CONCLUSION:CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. SHOULD ADDITIONAL INFORMATION BE MADE AVAILABLE, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT FILED.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THAT DURING THE PROCEDURE THE SURGEON ROTATED THE JAWS OF THIS BP2 DEVICE PAST THE "STOP BAR" AND DISLODGED THE PLASTIC STOP. THE PIECE WAS RECOVERED FROM THE CHEST CAVITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT EFFECT. THE BP2 DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BP2 ABLATION DEVICE OCL MEDTRONIC PERFUSION SYSTEMS 60831 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention