BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 7.5 FR - 30 CC

    MDR report key: 2852150 · Received November 12, 2012

    Report

    Report Number
    1219856-2012-00327
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PATIENT WHILE IN CARDIOLOGY. THE PATIENT NEEDED PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH INTRA-AORTIC BALLOON PUMP (IABP) THERAPY. THE VASCULAR SURGEON INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH VIA LEFT FEMORAL ARTERY WITH NO ISSUES. AFTER APPROXIMATELY 5 MINUTES THE CENTRAL LUMEN WAS FOUND UNABLE TO FLUSH OR ASPIRATE. AS A RESULT, THE IAB AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT SUCCESSFULLY. A NEW IAB WAS OPENED, PREPPED AND INSERTED VIA THE SAME INSERTION SITE SUCCESSFULLY. THERE WAS NO REPORT OF COMPLICATIONS OR INJURY. THERE WAS AN APPROXIMATE TEN MINUTE DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PATIENT NOTED. THE PATIENT OUTCOME IS THE PATIENT EXPIRED. PER THE VASCULAR SURGEON, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THE PATIENT EXPIRED THREE HOURS AFTER THE EVENT. PER THE M.D., THE PATIENT RECEIVED THERAPY OF PERCUTANEOUS CORONARY INTERVENTION (PCI) DUE TO HEART FAILURE. HOWEVER, THE PATIENT WAS TOO OLD ((B)(6)) TO BEAR THE PAIN OF THE THERAPY. HIS FAMILY FINALLY DECIDED TO GIVE UP THE THERAPY AND THEN THE PATIENT EXPIRED. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012 FROM THE DISTRIBUTOR STATED THAT THEY DID USE HEPARINIZED NNS WITH PRESSURE BAG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HEPARINIZED NNS