BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN

    MDR report key: 2953604 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00350
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DYG
    PMA / PMN Number
    K012225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PATIENT HAD ACUTE CARDIAC FAILURE AND HAD DIFFICULTY BREATHING. THE BALLOON CATHETER WAS REMOVED. THE PROCEDURE WAS ABANDONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56171 ATTAIN CATHETER, FLOW DIRECTED DYG RICE CREEK MFG 6215 61180466

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Life Threatening