BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 1934668 · Received November 24, 2010

    Report

    Report Number
    1219856-2010-00867
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PT WAS HAVING AN INTRA-AORTIC BALLOON (IAB) INSERTED IN THE CATH LAB. THE MD PUNCTURED THE LEFT FEMORAL ARTERY AND INSERTED A SUPER ARROW-FLEX (SAF) SHEATH WITH A DILATOR. THE ONE-WAY VALVE WAS ATTACHED AND THE BALLOON VACUUMED TWICE INSIDE THE TRAY AND WRAPPED TIGHTLY. THE CATHETER WAS REMOVED FROM THE TRAY HORIZONTALLY PER THE INSTRUCTIONS FOR USE. THE STARTED TO ADVANCE THE CATHETER THROUGH THE SHEATH WHEN THE BALLOON LOOSENED AND WOULD NOT PASS. THIS MD IS SKILLFUL AT THIS IAB SYSTEM. THE IAB CATHETER AND SHEATH WERE REMOVED TOGETHER. THERE WAS A 5 MINUTE DELAY IN THERAPY WHILE A NEW SAF SHEATH AND BALLOON KIT WAS OPENED AND INSERTED. IT WAS INSERTED VIA THE SAME INSERTION SITE SUCCESSFULLY. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS. THE PT HAD NO EXCESSIVE BLEEDING DURING THE PROCEDURE AND WAS LISTED IN "FINE" CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC. MF0042786

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK