BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1943957 · Received December 3, 2010

    Report

    Report Number
    1219856-2010-00870
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 30, 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 INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE CATH LAB AN INTRA-AORTIC BALLOON (IAB) CATHETER WAS BEING INSERTED IN A MALE, PT, WITH A MYOCARDIAL INFARCTION. 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. HE STARTED TO ADVANCE THE CATHETER THROUGH THE SHEATH, WHEN THE BALLOON STOPPED ADVANCING AND WOULD NOT PASS DUE TO CRITICAL RESISTANCE. THE IAB CATHETER AND SHEATH WERE REMOVED TOGETHER. THERE WAS A 10 MIN 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 NOTED. 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 MF0021654

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN