BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 7.5 FR - 30 CC

    MDR report key: 2061533 · Received March 16, 2011

    Report

    Report Number
    1219856-2011-00099
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE SICU (SURGICAL INTENSIVE CARE UNIT), THE MD INSERTED THE SHEATH (INSERTION SITE UNK). WHEN INSERTING THE INTRA-AORTIC BALLOON (IAB), THE MD FOUND IT DIFFICULT TO PASS THE IAB THROUGH THE SHEATH. THE MD REMOVED THE IAB FROM THE SHEATH AND INSERTED ANOTHER IAB SUCCESSFULLY. THERE WAS NO REPORTED PT DEATH OR INJURY. THERE WERE NO REPORTED PT COMPLICATIONS. THE OUTCOME OF THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 7.5 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF0118420

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR