BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PILOT GUIDE WIRE

    MDR report key: 1051752 · Received May 23, 2008

    Report

    Report Number
    2024168-2008-00425
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K984394
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-PERMANENT DAMAGE. REPORTING RATIONALE: PERFORATION AND CARDIAC TAMPONADE. DEVICE ISSUE: NONE. IT WAS REPORTED THAT DURING USE OF THE PILOT GUIDE WIRE, THE PT EXPERIENCED CARDIAC TAMPONADE SUGGESTING A PERFORATION OCCURRED. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE PILOT GUIDE WIRE 74DQX DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability