BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR -40 CC

    MDR report key: 1895510 · Received November 5, 2010

    Report

    Report Number
    1219856-2010-00804
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    REFERENCE MDR #1219856-2010-00802 FOR THE FIRST EVENT, MDR #1219856-2010-00803 FOR THE SECOND EVENT AND MDR #1219856-2010-00805 FOR THE FOURTH EVENT THE SAME PT. IT WAS REPORTED THAT THIS IS THE THIRD INTRA-AORTIC BALLOON (IAB) INSERTION ATTEMPT. THE PT WAS IN CARDIOGENIC SHOCK. THE DECISION WAS MADE TO USE INTRA-AORTIC COUNTER PULSATION. WHILE IN THE CARDIOLOGY UNIT, DURING INSERTION OF THE IAB WITH THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE PT'S LEFT FEMORAL ARTERY, THE PROXIMAL TIP OF THE BALLOON BLOCKED AT THE END OF THE SAF SHEATH. THE IAB AND SAF WERE REMOVED. AS A RESULT, THE MD REQUESTED ANOTHER IAB KIT FOR THE INSERTION AND SWITCHED TO THE RIGHT FEMORAL ARTERY. THE PT DID NOT RECEIVE INTRA-AORTIC COUNTER PULSATION. THERE WAS NO REPORTED PT DEATH. THE PT STATUS WAS CRITICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR -40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF0021654

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other