BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGATTA GUIDEWIRE

    MDR report key: 1061492 · Received June 16, 2008

    Report

    Report Number
    3006010712-2008-00011
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BRIVANT LTD
    Product Code
    DQX
    PMA / PMN Number
    K060551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION; HOWEVER, AS OF TO DATE, IT HAS NOT BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE DISTAL PART OF THE GUIDEWIRE FRACTURED. THE REPORT RECEIVED INDICATED THAT DURING THE PROCEDURE, THE DISTAL PART OF THE GUIDEWIRE GOT DISSECTED WHICH RESULTED IN THE NEED TO REMOVE THE WHOLE SET OF CATHETERS. THE PROBLEM OCCURRED IN THE COURSE OF AN ANGIOPLASTY, WHICH MAY HAVE POSED DANGER TO PATIENT'S HEALTH AND LIFE. IT WAS INDICATED THAT A COMPLICATION WAS RECORDED, RESULTING FROM A DEFECTIVE OPERATION OF THE REGATTA GUIDEWIRE. THE STEERING PROPERTY OF THE GUIDEWIRE WAS VERY POOR AND IT WAS DIFFICULT TO INTRODUCE THE GUIDEWIRES INTO THE PROPER ARTERY. THERE HAVE NOT BEEN ADVERSE CONSEQUENCES REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGATTA GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX BRIVANT LTD NA 90007122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK