BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR SYSTEMS INC CORONARY GUIDE WIRE

    MDR report key: 14074373 · Received April 8, 2022

    Report

    Report Number
    MW5108864
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    April 4, 2022
    Report Date
    April 6, 2022
    Manufacturer
    CARDIOVASCULAR SYSTEMS INC
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN PERFORMING CARDIAC CATHETERIZATION. WHILE TRYING TO REPOSITION THE CORONARY GUIDE WIRE IT SHEARED OFF AT THE TIP OF THE GUIDE CATHETER. FAULTY GUIDE WIRE REMOVED, NEW GUIDE WIRE USED FOR THE PROCEDURE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279174 CARDIOVASCULAR SYSTEMS INC CORONARY GUIDE WIRE CATHETER, PERIPHERAL, ATHERECTOMY MCW CARDIOVASCULAR SYSTEMS INC VIPERWIRE ADVANCE CORONARY 6128028

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention