BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1201793 · Received October 15, 2008

    Report

    Report Number
    2024168-2008-00945
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION-SIMILAR REPORTS ON RETURNED DEVICES TYPICALLY SHOWS THAT GUIDEWIRE TIP DAMAGE OF THIS NATURE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING TORQUING AND MANIPULATION. IN THIS CASE, THE LESION WAS HEAVILY CALCIFIED. THE WIRE TIP COULD HAVE BECOME TRAPPED IN OR ON CALCIFICATION IN THE LESION DURING ATTEMPTS TO CROSS. ALTHOUGH IT IS MOST LIKELY THE SEPARATION IS THE RESULT OF CASE CIRCUMSTANCES, A CONCLUSIVE ROOT CAUSE OF THE REPORTED PRODUCT EXPERIENCE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: SEPARATED GUIDEWIRE TIP REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: SEPARATED GUIDEWIRE TIP. IT WAS REPORTED THAT DURING USE OF THE DEVICE TO TREAT A HEAVILY CALCIFIED BIFURCATION LESION LOCATED IN THE DIAGONAL AND LEFT ANTERIOR DESCENDING(LAD), THE GUIDE WIRE TIP BECAME STUCK IN THE DIAGONAL AND BROKE OFF. THE GUIDE WIRE WAS THE ONLY DEVICE THAT HAD BEEN ADVANCED DURING THE PROCEDURE. ATTEMPTS TO SNARE THE SEPARATED TIP WERE UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY WHERE THE GUIDEWIRE TIP WAS REMOVED SUCCESSFULLY. THE PATIENT ALSO HAD A LIMA TO THE LAD. PATIENT REPORTED TO BE DOING WELL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8072291

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention| S