BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 1842068 · Received August 27, 2010

    Report

    Report Number
    1219856-2010-00580
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 26, 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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE CATH LAB A MALE PATIENT WAS PREPARED TO HAVE AN INTRA-AORTIC BALLOON (IAB) PLACED. THE BALLOON UNWRAPPED DURING INSERTION OF THE LEFT FEMORAL ARTERY. THE MD WITHDREW BOTH THE BALLOON AND SHEATH TOGETHER. HE OPENED A NEW KIT PLACING A NEW SHEATH AND BALLOON VIA THE SAME SITE. THERE WAS NO REPORTED PATIENT DEATH OR INJURIES. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE DELAY IN THERAPY WAS 10 MINUTES UNTIL A NEW IAB CATHETER WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS 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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK