BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1994268 · Received January 14, 2011

    Report

    Report Number
    1219856-2011-00012
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    Z-0790/0793-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 A FEMALE PT WAS IN THE CORONAROGRAPHY UNIT. THE SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED VIA THE RIGHT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH THE SHEATH WHEN IT BECAME BLOCKED. THE IAB AND SAF SHEATH WERE REMOVED TOGETHER. ANOTHER (B)(4) WAS INSERTED THROUGH A TEFLON SHEATH VIA THE SAME INSERTION SITE. THERE WERE NO PT DEATH, INJURIES OR COMPLICATIONS NOTED. THE PT OUTCOME WAS LISTED AS FINE.

    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 INTERNATIONAL INC MF0063420

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR