BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1842051 · Received August 27, 2010

    Report

    Report Number
    1219856-2010-00575
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U 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 INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL ARTERY. WHEN THE TIP OF THE IAB WAS INSERTED INTO THE SAF SHEATH THERE WAS RESISTANCE, BUT THE MD INSERTED THE IAB BY ROTATING IT INTO THE SAF SHEATH. IT WAS REPORTED THAT "AT THE TIP OF THE SAF SHEATH THE TIP OF THE IAB STUCK AND WOULD NOT COME OUT OF THE SHEATH." NEVERTHELESS, THE MD CONTINUED TO ADVANCE THE IAB THROUGH THE SAF SHEATH. THE IAB "WAS ADVANCED AND CAME OUT OF THE SHEATH, BUT THE REAR END OF THE BALLOON STUCK AT THE TIP OF THE SHEATH. AS A RESULT, THE IAB DID NOT COME OUT THE SAF SHEATH COMPLETELY." THE IAB AND SAF SHEATH WERE REMOVED AS ONE UNIT. IN THE SAME INSERTION SITE (LEFT FEMORAL ARTERY) A NEW ARROW IAB WAS INSERTED THROUGH A TERUMO 9FR SHEATH WITHOUT DIFFICULTIES. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. IT IS "UNKNOWN" IF THERE WAS A DELAY IN THERAPY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE OUTCOME OF THE PATIENT IS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF9110244

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR TERUMO 9 FR SHEATH