BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 30 CC

    MDR report key: 3063307 · Received April 11, 2013

    Report

    Report Number
    1219856-2013-00095
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    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 EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE MD PREPPED THE INTRA-AORTIC BALLOON (IAB) AND PULLED NEGATIVE BEFORE PULLING THE IAB OUT OF THE TRAY. THE MD INSERTED THE TEFLON SHEATH INTO THE PATIENT'S FEMORAL ARTERY. AS THE MD WAS INSERTING THE IAB THROUGH THE SHEATH, RESISTANCE WAS MET. AS A RESULT, THE IAB WAS NOT USED. ANOTHER IAB WAS PREPPED AND INSERTED IN THE SAME INSERTION SITE WITHOUT ISSUE. THERE WERE NO REPORTED PATIENT COMPLICATIONS, INJURY OR DEATH. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. AS REPORTED THERE WAS NO DELAY OR INTERRUPTION IN IABP THERAPY. THE PATIENT OUTCOME IS LISTED AS GOOD. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 STATED THE IAB WAS PREPPED PER INSTRUCTION AND THE BALLOON MEMBRANE WAS IMMERSED IN STERILE SALINE PRIOR TO INSERTION. IT IS UNKNOWN HOW MUCH OF THE IAB WAS INSERTED INTO THE SHEATH WHEN THE RESISTANCE WAS MET. THE MD REMOVED THE IAB AND THE SHEATH AS ONE UNIT ALLOWING THE SPRING WIRE GUIDE TO REMAIN IN PLACE. A SECOND SHEATH WAS INSERTED AND ANOTHER IAB WAS INSERTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156844 IAB: 7.5 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF2073577

    Patients

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