BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 2860010 · Received December 4, 2012

    Report

    Report Number
    1219856-2012-00344
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    October 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    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 FEMALE PATIENT THAT EXPIRED WHILE IN THE SURGICAL CENTER. INDICATION FOR USE: DIFFICULTY OUTPUT OF EXTRACORPOREAL CIRCULATION. THE PATIENT'S SIXTH REOPERATION OF MITRAL VALVE EXCHANGE INTRAOPERATIVELY WAS DIFFICULT TO EXIT FROM EXTRACORPOREAL CIRCULATION DEVICE REQUIRING USE OF INTRA-AORTIC, BUT AFTER BEGINNING TO USE THE SYSTEM EBBED BLOOD. THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH VIA RIGHT FEMORAL ARTERY WITH NO ISSUES NOTED. WITHIN APPROXIMATELY 5 MINUTES THE REFLUX OF BLOOD WAS OBSERVED. AS A RESULT, THE IAB AND SHEATH WERE REMOVED. A NEW IAB WAS INSERTED VIA THE SAME INSERTION SITE (RIGHT FEMORAL ARTERY) USING THE SAME SPRING WIRE GUIDE THAT WAS LEFT IN SUCCESSFULLY. THE NEW IAB SHOWED GOOD PERFORMANCE, RUNNING ALL THE TIME. THEY WERE ABLE RETURN TO EXTRACORPOREAL CIRCULATION. THERE WAS NO REPORT OF COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A 2 MINUTE DELAY OR INTERRUPTION IN THERAPY NOTED. THE MD STATED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THE PATIENT EXPIRED DUE TO MYOCARDIA FAILURE, EVEN WITH THE HELP OF THE MEDICAL DEVICE. THE PATIENT DID NOT TOLERATE THE SURGICAL STRESS.

    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. KF2012215

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR INTRA-AORTIC BALLOON PUMP