BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 1231642 · Received November 14, 2008

    Report

    Report Number
    2024168-2008-01147
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/SURGICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: GUIDE WIRE TIP CAUGHT IN DEPLOYED STENT REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: DIFFICULT TO REMOVE. IT WAS REPORTED THAT WHEN THE GUIDE WIRE WAS RETRACTED AFTER A SUCCESSFUL STENT IMPLANTATION A RESISTANCE WAS FELT. THE GUIDE WIRE TIP HAD INTERLOCKED WITH THE DISTAL STRUTS OF THE STENT IMPLANT, AND THE STENT WAS TIGHTENED ON THE DISTAL END OF THE GUIDE WIRE. AN OTW BALLOON CATHETER WAS USED IN AN ATTEMPT TO REMOVE THE GUIDE WIRE; BUT WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO ANOTHER HOSPITAL FOR BYPASS SURGERY. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8082592

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R| S STENT: DRIVER 3.5 X 18| GUIDE CATH: 6F JL4