BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 4163318 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02990
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K123153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE IMPLANTING DOCTOR COMMENTED THAT SOME RESISTANCE WAS FELT WHEN THE DILATOR WAS INSERTED INTO THE GUIDING CATHETER AFTER FLUSHING DURING PREPARATION. THE COMPANY REPRESENTATIVE NOTICED THAT THE PHYSICIAN WAS HOLDING THE PROXIMAL PART OF DILATOR (AWAY FROM THE VALVE) WHILE INSERTING THE DILATOR INTO THE CATHETER, AND ADVISED THE PHYSICIAN TO POSITION THEIR HOLD OF THE DILATOR CLOSER TO THE VALVE. IT DID NOT PROCEED WELL SO THE GUIDING CATHETER WAS FLUSHED AGAIN, AND THE DILATOR WAS RE-INSERTED. WHEN EXTRACTING THE DILATOR AFTER THE CATHETER WAS INSERTED INTO THE PATIENT BODY, BLOOD WAS LEAKING FREELY FROM THE VALVE. ALTHOUGH IT WAS ALSO CONSIDERED TO USE ANOTHER SHEATH, ONLY THE VALVE WAS REPLACED AND THE PROCEDURE WAS CONTINUED. THE SAME ISSUE OCCURRED AFTERWARDS WITH THE INNER CATHETER, NOT MUCH BLOOD LEAKED BECAUSE THE LEAD WAS INSERTED IMMEDIATELY. THE LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644723 ATTAIN SELECT II CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC. 6248VI-90S

    Patients

    Seq Age Sex Outcome Treatment
    1