BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 2201466 · Received August 3, 2011

    Report

    Report Number
    1219856-2011-00284
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 29, 2011
    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 EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER THE INSTRUCTIONS FOR USE. THE PATIENT DID NOT HAVE TORTUOUS VESSELS HOWEVER, VERY MILD CALCIFICATION APPEARED ON "CINE IMAGES." IT WAS ALSO NOTED THAT THE PATIENT HAD AN INFECTIOUS DISEASE. WHEN THE FIBEROPTIX SENSOR (FOS) CONNECTOR AND THE CAL KEY WERE CONNECTED TO THE PUMP, THE PUMP DID NOT RECOGNIZE THE FOS CONNECTOR. NEVERTHELESS, THE IAB WAS INSERTED VIA A TEFLON SHEATH INTO THE PATIENT'S LEFT FEMORAL ARTERY. SOON AFTER THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY BEGAN, THE PUMP ALARMED HELIUM LEAK AND BLOOD WAS NOTICED IN THE DRIVE LINE TUBING. AS A RESULT, THE IAB AND TEFLON SHEATH WERE REMOVED AND THE MD INSERTED AN IAB-06840-U SUCCESSFULLY. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO REPORTED DELAY OR INTERRUPTION IN IAB THERAPY. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT OUTCOME IS LISTED AS "GOOD." ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011 FROM TELEFLEX (B)(4) OFFICE STATED "THE INSERTION SITE OF THE IAB-06840-U WAS THE LEFT FEMORAL ARTERY, SAME AS THE FIRST INSERTION SITE. THERE WERE NO REPORTED DELAY OR INTERRUPTION OF THERAPY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF1019204

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK