BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 3863240 · Received June 10, 2014

    Report

    Report Number
    9612164-2014-00596
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K053431
    Product Problem
    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE CATHETER WAS RETURNED AND ANALYZED. THE MECHANICAL OPERATION OF THE CATHETER SHAFT WAS PEELING/SLITTING/ SPLITTING, SHOWING A SPIRAL SLIT, AND WAS BENT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT THE SLITTER WAS NOT RETURNED, AND THAT THE CATHETER WAS RECEIVED IN TWO PIECES WITH THE SHAFT SEPARATED FROM THE HANDLE. THE SPIRAL SLITTING AND BENT SHAFT WAS OBSERVED DURING ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HUB AND HANDLE ASSEMBLY OF THE DELIVERY CATHETER TORE OFF DURING THE CATHETER SLITTING PROCESS. THE PHYSICIAN WAS ABLE TO COMPLETE SLITTING USING SURGICAL INSTRUMENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339202 ATTAIN SELECT II CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6248V-90 0007000015

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR