BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1915491 · Received November 5, 2010

    Report

    Report Number
    1219856-2010-00806
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 4, 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). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB A MALE PT WAS HAVING AN INTRA-AORTIC BALLOON (IAB) INSERTED AS AN EMERGENT CASE. THE PHYSICIAN INSERTED THE CATHETER IN THE SHEATH VIA THE LEFT FEMORAL ARTERY. HE ENCOUNTERED SLIGHT DIFFICULTY, BUT HE KEPT INSERTING THE CATHETER. WHEN THE CATHETER WENT INTO THE ARTERY, IT WAS NOTED THE BALLOON WAS RUPTURED. THE IAB CATHETER AND SHEATH WERE REMOVED TOGETHER AND REPLACED WITH A IAB-06840-U. THE SECOND INSERTION WAS COMPLETED WITHOUT PROBLEMS AND THE PUMP WAS USED. IT WAS NOTED THAT THE PT BLOOD VESSELS WERE NORMAL AND NOT CALCIFIED. THERE WAS NO PT DEATH, INJURY OR COMPLICATIONS NOTED. IT IS UNK IF THERE WAS A DELAY IN THERAPY WHILE A NEW IAB WAS INSERTED. THE PT'S OUTCOME WAS LISTED AS 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. MF0073848

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP