BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II + SUREVALVE

    MDR report key: 6063339 · Received October 28, 2016

    Report

    Report Number
    6063339
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 16, 2016
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING BIV ICD, THE PHYSICIAN REMOVED THE CS INNER GUIDE CATHETER. THE OUTER CONSTRUCTION/COATING OF THE CATHETER PEELED AWAY IN MULTIPLE PIECES. THE CATHETER ALSO PROCEEDED TO BREAK INTO TWO PIECES. IT WAS SUCCESSFULLY REMOVED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716315 ATTAIN SELECT II + SUREVALVE CATHETER, PERCUTANEOUS DQY MEDTRONIC VASCULAR 6248V-130 0007810132

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR