BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RECOVER LP 2.5 PECUTANEOUS CARDIAC S

    MDR report key: 1111016 · Received August 12, 2008

    Report

    Report Number
    1220648-2008-00009
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 13, 2008
    Manufacturer
    ABIOMED
    Product Code
    KFM
    PMA / PMN Number
    K063723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, A FAILURE ANALYSIS CANNOT BE COMPLETED TO DETERMINE THE ROOT CAUSE OF THE REPORTED DEVICE DEFECT OR THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT (BLOOD LOSS REQUIRING TRANSFUSION). A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION CAN BE OBTAINED.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE INVOLVING AN IMPELLA 2.5 DEVICE. DURING THE INITIAL INSERTION TECHNIQUE OF THE DEVICE, THE 13FR PEEL-AWAY INTRODUCER, AN ACCESSORY OF THE DEVICE'S INTRODUCER KIT, WAS OBSERVED TO BE LEAKING FROM THE HEMOSTATIC VALVE AROUND THE IMPELLA CATHETER. THE BLEEDING WAS DISCOVERED WHILE THE PHYSICIAN WAS BACKLOADING THE 7FR SHEATH. THE SHEATH CONTINUED TO LEAK AROUND THE IMPELLA CATHETER. AN ESTIMATED BLOOD LOSS OF 600CC WAS OBSERVED FROM THE HEMOSTATIC VALVE, SO A BLOOD TRANSFUSION WAS PERFORMED INTRA-OPERATIVELY. IT WAS DECIDED TO GIVE 2 UNITS OF PACKAGED RED BLOOD CELLS BEFORE REMOVAL OF PUMP. THE PATIENT WAS ALSO GIVEN 40MG IV LASIX INTRA-PROCEDURE, AND TOTAL UOP FOR THE PROCEDURE WAS 2 LITRES. THE PATIENT SEEMED MUCH IMPROVED AFTER THE PROCEDURE (SBP STAYING AROUND 115, PAP DECREASED TO 59/26). THE IMPELLA WAS SUCCESSFULLY WEANED OVER APPROXIMATELY 30 MIN, WITHOUT HEMODYNAMIC COMPROMISE, AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPELLA RECOVER LP 2.5 PECUTANEOUS CARDIAC S KFM ABIOMED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention