BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 1711616 · Received May 26, 2010

    Report

    Report Number
    1219856-2010-00348
    Event Type
    Malfunction
    Date Received
    May 26, 2010
    Date of Event
    April 30, 2010
    Report Date
    May 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE IAB WAS CORRECTLY PREPPED AND VACUUM PULLED AS PER THE INSTRUCTIONS FOR USE. AFTER INSERTING THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE PT'S FEMORAL ARTERY, THE MD INSERTED THE IAB INTO THE SAF SHEATH. AFTER INSERTING THE TIP OF THE IAB THROUGH THE SAF SHEATH, THE DISTAL PART OF THE MEMBRANE BECAME COMPLETELY UNWRAPPED WITH A BULGE AT THE PROXIMAL PART OF THE MEMBRANE. AS A RESULT, THE BALLOON BECAME STUCK IN THE SAF SHEATH. THE IAB WAS REMOVED FROM THE SAF SHEATH, THE SAF SHEATH REMAINED IN THE PT'S FEMORAL ARTERY AND ANOTHER IAB WAS PREPPED AND SUCCESSFULLY INSERTED. THE PT WAS NOT INJURED AND IT IS UNK IF THERE WAS A DELAY OR INTERRUPTION IN THERAPY. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS 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. MF9056839

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK