BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIWIRE PRESSURE GUIDE WIRE

    MDR report key: 19843607 · Received July 26, 2024

    Report

    Report Number
    3008363989-2024-00045
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 9, 2024
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    UDI-DI
    00845225003043
    PMA / PMN Number
    K192886
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿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

    Additional Manufacturer Narrative · 0

    BLOCKS D9 & H3: THE OMNIWIRE WAS RETURNED FOR EVALUATION. BLOCK H3: THE OMNIWIRE WAS RETURNED WITHOUT THE DISTAL PORTION (INCLUDES DISTAL COIL, DOME AND SHAPING RIBBON). THE RETURNED PORTION (INCLUDES CORE WIRE, DISTAL, SENSOR HOUSING AND COMPOSITE CORE) MEASURED APPROX. 189.5 CM FROM THE DISTAL END TO THE EXPOSED CORE WIRE. THE OVERALL WORKING LENGTH MEASUREMENT SPECIFICATION IS 190 +/-5 CM. ALTHOUGH THE COMPLAINT DETAILS STATE THAT APPROX. 1.5 CM WAS STENTED TO THE VESSEL WALL, LAB ANALYSIS DETERMINED THAT APPROX. 3 CM OF THE RADIOPAQUE TIP (DISTAL COIL) WAS LIKELY RETAINED IN THE PATIENT. BLOCK H6: THE PROBABLE CAUSE OF THE TIP SEPARATION IS LIKELY DUE TO ROUGH HANDLING. MANIPULATION, STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE RESULTING IN THE REPORTED FAILURE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE IN A SLIGHTLY CALCIFIED PROXIMAL CIRCUMFLEX. DURING USE, RESISTANCE WAS ENCOUNTERED AND THE TIP GOT STUCK IN THE VESSEL. AFTER SEVERAL ATTEMPTS TO REMOVE THE WIRE, APPROX. 15 MM OF THE TIP BROKE AND WAS STENTED TO THE VESSEL WALL. THE PATIENT WAS DISCHARGED NORMALLY THE FOLLOWING DAY. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING INTERVENTION, BUT RETAINED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533686 OMNIWIRE PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 89185 0303133220 00845225003043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female GUIDE CATHETER, MFG AND SIZE UNK| INTRODUCER SHEATH, MFG AND SIZE UNK| PHILIPS: INTRASIGHT CONSOLE