BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN

    MDR report key: 2053213 · Received April 13, 2011

    Report

    Report Number
    2182208-2011-00540
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 31, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYG
    PMA / PMN Number
    K012225
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE CATHETER WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. LAB PERSONNEL NOTED THAT BLOOD IS VISIBLE AT VARIOUS LOCATIONS ON THE CATHETER AND USING A FRESH SYRINGE THE BALLOON WAS TESTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON CATHETER WAS ADVANCED IN THE CORONARY SINUS THROUGH A CANNULATION CATHETER. WHEN THE BALLOON WAS INFLATED, IT COULD NOT BE VISUALIZED UNDER FLUOROSCOPY AND THE VEIN WAS NOT BLOCKED. THE CATHETER WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN LEFT HEART DELIVERY SYSTEM DYG MEDTRONIC, INC. 6215 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other