BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 3694628 · Received December 17, 2013

    Report

    Report Number
    1219856-2013-00312
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Date of Event
    December 1, 2013
    Report Date
    December 2, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE CATH LAB DURING USE. AN IAB-05840 LWS WAS OPENED BY ACCIDENT AND THE USER DECIDED TO USE IT. THE DOCTOR INSERTED THE INTRA-AORTIC BALLOON (IAB) BEFORE IT WAS ZEROED. THEY ATTEMPTED TO ZERO AFTER INSERTION THROUGH THE SHEATH WITH SIDEPORT VIA RIGHT FEMORAL W/O ISSUE AND IT DID NOT ZERO. ANOTHER PUMP WAS TRIED UNSUCCESSFULLY. AS A RESULT, THE DOCTOR DECIDED TO REMOVE THE IAB AND SHEATH TOGETHER AS ONE UNIT. A NEW IAB WAS RETRIEVED. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PT OUTCOME IS OKAY. REFERENCE MDR #1219856-2013-00311 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659703 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRA-AORTIC BALLOON PUMP