BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 1992420 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00181
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 1, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K053431
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: THE CATHETER WAS PARTIALLY RETURNED IN SEGMENTS AND ANALYZED. THE PRIMARY ANALYSIS REVEALED CATHETER SEPARATION. IT WAS ALSO NOTED THAT THE CATHETER WAS KINKED, HAD A ROUGH SLIT EDGE, AND HAD IMPLANT DAMAGE. LAB PERSONNEL ALSO NOTED THAT THE SLITTER WAS NOT RETURNED AND THE CATHETER WAS KINKED IN VARIOUS LOCATIONS, EVIDENCE OF SLITTING DIFFICULTY SUCH AS CHATTER AND RADIAL CRACKING. CATHETER WAS SLIT SPIRALLY (TECHNIQUE ISSUE), BUT WAS SLIT ENTIRELY. CATHETER SEPARATED AT TWO LOCATIONS APPROXIMATELY 4CM AND 11CM FROM HUB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD A PROBLEM WITH CUTTING A CATHETER WITH A SLITTER. ACCORDING TO THE PHYSICIAN "IT WAS IMPOSSIBLE TO CUT IT WITH THIS NEW SLITTER." THE PHYSICIAN HAS USED THE SLITTER IN THE PAST WITHOUT ANY PROBLEMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD A PROBLEM WITH CUTTING A CATHETER WITH A SLITTER. ACCORDING TO THE PHYSICIAN "IT WAS IMPOSSIBLE TO CUT IT WITH THIS NEW SLITTER." THE PHYSICIAN HAS USED THE SLITTER IN THE PAST WITHOUT ANY PROBLEMS. 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, INC. 6248DEL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other