BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1881138 · Received October 1, 2010

    Report

    Report Number
    1219856-2010-00685
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 30, 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 INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PT WAS IN THE CATH LAB HAVING AN INTRA-AORTIC BALLOON (IAB) INSERTED WHEN THE INCIDENT OCCURRED. THE SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED VIA THE LEFT FEMORAL ARTERY. WHEN THE PHYSICIAN INSERTED THE IAB CATHETER, IT COULD NOT BE ADVANCED THROUGH THE SHEATH. THE PHYSICIAN REMOVED THE CATHETER AND SHEATH TOGETHER, OPENED A NEW KIT AND BALLOON AND FINISHED THE PROCEDURE. THERE WAS NO REPORTED PT DEATH, INJURIES OR COMPLICATIONS. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE DELAY IN TREATMENT WAS ABOUT 10 MINUTES TO REMOVE AND REPLACE THE PRODUCT. THE PT OUTCOME IS LISTED AS FINE.

    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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK