BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1934603 · Received November 24, 2010

    Report

    Report Number
    1219856-2010-00855
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    September 13, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CARDIO-THORACIC SURGERY INTENSIVE CARE UNIT, THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED SHEATHLESS INTO THE PT'S RIGHT FEMORAL ARTERY. A LEAK WAS NOTICED AT THE SITE OF ARTERIAL LINE CONNECTOR. AS A RESULT, THE IAB WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS REQUIRED; HOWEVER, NOT DUE TO THIS REPORTED ISSUE. THE PT WAS TAKEN TO THE OPERATING ROOM FOR A CORONARY ARTERY BYPASS GRAFT. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT OUTCOME IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF9077957

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR