BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 3861482 · Received June 10, 2014

    Report

    Report Number
    9612164-2014-00600
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS 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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE CATHETER WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE MECHANICAL OPERATION OF THE CATHETER PEELING/SL ITTING/SPLITTING SHOWED A SPIRAL SLIT. THE MECHANICAL OPERATION OF THE CATHETER WAS DAMAGED. THE MECHANICAL OPERATION OF THE CATHETER PEELING/SLITTING/SPLITTING WAS PARTIALLY EXECUTED. 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 THE IMPLANT PROCEDURE THE PHYSICIAN SLIT THE SUB-SELECTOR, WHICH SPIRALED AND THE HUB SNAPPED OFF. AN ATTEMPT WAS MADE TO CUT IT WITHOUT SUCCESS. THE DELIVERY CATHETER WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342494 ATTAIN SELECT II CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6248VI-90 0006935971

    Patients

    Seq Age Sex Outcome Treatment
    1