BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 2203607 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11715
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DQY
    PMA / PMN Number
    K053431
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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: (B)(4): THE SLITTER BLADE WAS DAMAGED AND APPEARS TO HAVE BEEN HELD AT AN ANGLE WHILE SLITTING, PRODUCING MANY SCRAPE MARKS ON ONE SIDE AND SLIGHT SCRAPES ON THE OTHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO SLIT THE CATHETER, THE CATHETER SEVERED. ONE THIRD OF THE CATHETER REMAINED INSIDE THE INTRODUCING SYSTEM. ANOTHER SLITTER WAS OPENED AND THE PHYSICIAN WAS SUCCESSFUL IN REMOVING THE REMAINING CATHETERS. NO PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) LEFT HEART DELIVERY SYSTEM