BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM

    MDR report key: 3860428 · Received June 10, 2014

    Report

    Report Number
    9612164-2014-00585
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K061480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE CATHETER WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE MECHANICAL OPERATION OF THE CATHETER SHAFT WAS BENT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    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. (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 THE IMPLANT ATTEMPT, AFTER PLACING THE LEFT VENTRICULAR LEAD AND DURING SLITTING, THE SLITTER CONTACTED THE PULL WIRE OF THE CATHETER AND THE SLITTER STOPPED AND COULD NOT MOVE. THE FORCE OF THE SLITTING MANEUVER WAS TRANSMITTED TO THE ALREADY SLIT PORTION OF THE CATHETER CAUSING THE CATHETER TO TEAR AT THE POINT OF CONTACT WITH THE PULL WIRE. THE REMAINING PORTION OF THE CATHETER THAT WAS STILL SURROUNDING THE LEAD HAD TO BE SLICED OFF THE LEAD BODY WITH SCISSORS. THE REMNANTS OF THE CATHETER WERE REMOVED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341804 ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6227DEF04 0007026293

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR