BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RECOVER LP 2.5 CARDIAC SUPPORT SYSTEM

    MDR report key: 1082142 · Received July 25, 2008

    Report

    Report Number
    1220648-2008-00007
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 24, 2008
    Manufacturer
    ABIOMED, INC.
    Product Code
    KFM
    PMA / PMN Number
    K063723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED, UNABLE TO FOLLOW-UP. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION CAN BE REASONABLY OBTAINED. (B) (4).

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED TO ABIOMED, INC THAT A PATIENT (AGE AND GENDER UNKNOWN) HAD UNDERGONE A PROCEDURE INVOLVING THE USE OF AN IMPELLA 2.5 DEVICE. DURING THE PROCEDURE, THERE WAS A PROBLEM DURING THE IMPLANTATION" WITH THE SHEATH. IT WAS REPORTED THAT WHILE THE SHEATH WAS "INSIDE THE PUNCTUATION", THE "HEAD PART OF THE SHEATH LOOSENED FROM THE SHAFT UNEXPECTEDLY AND WITHOUT ANY MECHANICAL INFLUENCE". THE PROBLEM WAS NOT NOTICED IMMEDIATELY BY THE PHYSICIAN. THE COMPLAINT REPORTED THAT THE PATIENT "LOST QUITE A LOT OF BLOOD". THE BLEEDING WAS STOPPED USING A "BACKUP 13F SHEATH". THE INCIDENT HAD NO FURTHER IMPACT ON THE PATIENT'S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPELLA RECOVER LP 2.5 CARDIAC SUPPORT SYSTEM KFM ABIOMED, INC. LP2.5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other