BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 2033899 · Received February 11, 2011

    Report

    Report Number
    1219856-2011-00052
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    Z-0790/0793-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CARDIAC CARE UNIT, THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE PATIENT'S LEFT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS PASSED THROUGH THE SAF SHEATH AND BECAME STUCK INSIDE THE SHEATH. THE MD REMOVED THE IAB AND THE SAF SHEATH AS ONE UNIT. A DATASCOPE IAB WAS PREPPED AND USED WITHOUT DIFFICULTY. THERE WAS NO REPORTED PT DEATH INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE THERAPY WAS DELAYED FOR 20 MINUTES. THERE WERE NO REPORTED PT COMPLICATIONS. THE OUTCOME OF THE PT IS THAT THE PT SUCCESSFULLY REC'D HIS INTRA-AORTIC BALLOON PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF0087756

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR DATASCOPE IAB| INTRA-AORTIC BALLOON PUMP (BRAND UNK)