BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2201316 · Received August 3, 2011

    Report

    Report Number
    1219856-2011-00280
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 OCCURRED WHILE IN THE CATH LAB. DURING A SALES CALL, THE INTRA-AORTIC BALLOON (IAB) WAS GIVEN TO THE SALES REPRESENTATIVE AND THE ONLY INFORMATION ABOUT THE EVENT IS A STICKER ON THE BAG THAT THE IAB WAS SAVED IN THAT SAID "CLOTTED." THE CLINICAL RESOURCE CATH LAB RN DID NOT HAVE ANY FURTHER INFORMATION. THERE WAS NO REPORT OF PT DEATH. THE SALES REPRESENTATIVE SPOKE WITH THE CLINICAL LEAD AND THE INVENTORY SPECIALIST, WHO COULD NOT PROVIDE ADDITIONAL INFORMATION ABOUT THE EVENT. THE SALES REPRESENTATIVE ADDED THAT THE IAB IS STILL WRAPPED PRETTY TIGHTLY SO IT APPEARS AS IT WAS NEVER INFLATED. ALSO, THERE WAS NO SHEATH ON THE IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC KR1039680

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK