BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1944033 · Received December 3, 2010

    Report

    Report Number
    1219856-2010-00881
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 2, 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 THE MD PUNCTURED A PATIENTS' LEFT FEMORAL ARTERY AND INSERTED A SUPER ARROW-FLEX (SAF) SHEATH WITH DILATOR. THE MD ATTACHED A BLUE ONE-WAY VALVE AND VACUUMED THE BALLOON CATHETER TO WRAP THE BALLOON TIGHTLY WHILE IT WAS INSIDE OF THE TRAY. THEN THE MD REMOVED THE IAB CATHETER PARALLEL TO THE TRAY. DURING THE INSERTION, THE IAB STOPPED ADVANCING AND STUCK IN THE SAF SHEATH. THE MD REMOVED THE SAF SHEATH AND IAB TOGETHER FROM THE SITE. A NEW KIT WAS REQUESTED AND PREPPED FOR INSERTION. THE MD USED THE SAME INSERT SITE (LEFT FEMORAL ARTERY) FOR INSERTING THE NEW SAF SHEATH AND IAB. THE RESULT OF THE SECOND INSERTION WAS GOOD AND THE PATIENT OUTCOME WAS FINE. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A DELAY IN THERAPY UNTIL THE SECOND IAB COULD BE PREPPED AND INSERTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN