BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 2201460 · Received August 3, 2011

    Report

    Report Number
    1219856-2011-00292
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 2, 2011
    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 WHILE IN THE CARDIO CATH LAB THE MD PROPERLY PULLED THE VACUUM ON THE INTRA-AORTIC BALLOON (IAB) WHILE IT REMAINED INSIDE OF THE TRAY. THE TEFLON SHEATH WAS INSERTED VIA THE PATIENT'S LEFT FEMORAL ARTERY. THE MD COULD NOT ADVANCE THE IAB INTO THE CORRECT POSITION AND, AS A RESULT, THE IAB AND THE TEFLON SHEATH WERE REMOVED AS ONE UNIT. THERE WAS NO EXCESSIVE BLEEDING. ACCORDING TO THE REPORT, THE IAB CATHETER FRACTURED WHILE REMOVING FROM THE PATIENT. THE MD INSERTED A SECOND SHEATH AND IAB INTO THE SAME INSERTION SITE (LEFT FEMORAL ARTERY) WITHOUT COMPLICATIONS. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A REPORTED DELAY IN INTRA-AORTIC BALLOON PUMP (IABP) THERAPY FOR THE TIME FRAME IT TOOK TO PREP AND INSERT THE SECOND IAB SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT OUTCOME IS LISTED AS "NO COMPLICATIONS TO THE PATIENT."

    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