BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN

    MDR report key: 3860033 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05625
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MPRI
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS UNABLE TO CANNULATE THE TARGET VEIN AND WAS SUBSEQUENTLY REMOVED AND REPLACED. THE DELIVERY CATHETER WAS UTILIZED DURING THE ATTEMPT TO ENGAGE THE LEFT VENTRICULAR (LV) LEAD AND THERE WERE NO ALLEGED DEVICE MALFUNCTIONS AND/OR ISSUES THAT OCCURRED. HOWEVER DURING THE PROCEDURE AND ATTEMPT TO ENGAGE TARGET VEIN THE PATIENT ENCOUNTERED AN APPARENT CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT IS REPORTED AS STABLE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341825 ATTAIN CATHETER, PERCUTANEOUS DQY MPRI 6248V-130 0007018956

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Life Threatening| R