BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 1172857 · Received September 19, 2008

    Report

    Report Number
    1219856-2008-00444
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A FEMALE, PATIENT DIAGNOSIS IS ACS (ACUTE CORONARY SYNDROME). THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE MD INSERTED THE SHEATH VIA THE FEMORAL ARTERY. WHILE INSERTING THE IAB THROUGH THE SHEATH, IT BECAME STUCK. THE MD REMOVED THE IAB WITH THE SHEATH AS ONE UNIT. ANOTHER IAB WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC. MF8061125

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK