BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 1881112 · Received October 1, 2010

    Report

    Report Number
    1219856-2010-00684
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 6, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ARROW INTL., 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 A MALE PT WAS HAVING AN INTRA-AORTIC BALLOON (IAB) PLACED. THE SUPER ARROW-FLEX (SAF) SHEATH WAS PLACED IN THE LEFT FEMORAL ARTERY AND WHEN THE PHYSICIAN INSERTED THE IAB IT BECAME STUCK. THE PHYSICIAN COULD NOT ADVANCE THE CATHETER, DUE TO SEVERE RESISTANCE, SO HE REMOVED THE IAB AND SHEATH TOGETHER. THE PHYSICIAN OPENED A NEW SAF SHEATH AND BALLOON CATHETER KIT USING THE SAME INSERTION SITE AND FINISHED THE PROCEDURE. THE PT EXPERIENCED NO EXCESSIVE BLEEDING DURING THE PROCEDURE OR COMPLICATIONS. THERE WAS NO PT DEATH OR INJURIES. THE DELAY IN TREATMENT WAS ABOUT 10 MINUTES, WITH THE PT OUTCOME LISTED AS FINE.

    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. MF9099357

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK