BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM

    MDR report key: 3993924 · Received August 8, 2014

    Report

    Report Number
    9612164-2014-01047
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K061480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    PRODUCT EVENT SUMMARY: THE CATHETER WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE MECHANICAL OPERATION OF THE CATHETER PEELING/SLITTING/SPLITTING SHOWED A SPIRAL SLIT AND THE MANIPULATOR WIRE WAS BROKEN. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    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 SLITTING OF THE GUIDE CATHETER WAS HAMPERED IN SUCH A WAY THAT THE WIRE MESH OF THE CATHETER WAS NOT CUT COMPLETELY. THE PHYSICIAN USED ANOTHER SLITTER TO CUT SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469690 ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6227DEF04 0007008339

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR