BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPHER MS GUIDE WIRE

    MDR report key: 1051322 · Received May 22, 2008

    Report

    Report Number
    2024168-2008-00420
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE SEPARATION HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE GUIDE WIRE TIP SEPARATED. NO PATIENT INJURY OR INTERVENTION WAS REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPHER MS GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK