BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 2812581 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15944
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 6, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DQY
    PMA / PMN Number
    K053431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: (B)(4) THE CATHETER WAS RETURNED AND ANALYSIS FOUND THAT IT WAS SLIT SPIRALLY (TECHNIQUE ISSUE) AND THE SLITTER WAS NOT RETURNED. THERE WAS BLOOD ON THE CATHETER AND IT WAS KINKED AT VARIOUS LOCATIONS. THERE WAS CATHETER SEPARATION AT 28 CM FROM THE HUB. VISUAL ANALYSIS NOTED THAT THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO CUT THROUGH HUB AND THAT IT REQUIRED RE-THREADING THE CATHETER IN THE UNIVERSAL SLITTER. PART WAY INTO THE CUT, THE CATHETER BROKE OFF REQUIRING RE-THREADING OF SLITTER REMAINING CATHETER STILL IN THE BODY. THE CATHETER WAS REMOVED SUCCESSFULLY WITHOUT DISPLACING THE CORONARY SINUS (CS) LEAD OR CAUSING ANY PROBLEMS FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN SELECT II LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC PUERTO RICO, INC. 6248DEL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD