BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE SS GUIDEWIRE

    MDR report key: 707451 · Received May 1, 2006

    Report

    Report Number
    6000093-2006-00775
    Event Type
    Malfunction
    Date Received
    May 1, 2006
    Date of Event
    March 31, 2006
    Report Date
    April 3, 2006
    Manufacturer
    LAKE REGION MFG, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED INTERVENTION PROCEDURE, THE ZIPWIRE SS GUIDWIRE WOULD NOT STAY SLICK. THE PHYSICIAN HAD TO KEEP RE-WETTING IT. THE GUIDE CATHETER WAS GETTING STUCK. THE GUIDEWIRE COATING PEELED AWAY. NO PT COMPLICATIONS WERE REPORTED. CURRENT PT STATUS IS REPORTED AS 'FINE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE SS GUIDEWIRE PTA GUIDE WIRE DQX LAKE REGION MFG, INC. GSS/WIRE 035/80 ANG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN