BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO ELITE LASER ATHERECTOMY CATHETER

    MDR report key: 12032342 · Received June 17, 2021

    Report

    Report Number
    MW5101982
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Report Date
    June 16, 2021
    Manufacturer
    SPECTRANETICS CORP
    Product Code
    PDU
    UDI-DI
    00813132024710
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TURBO ELITE LASER ATHERECTOMY CATHETER WAS KINKED AND GOT STUCK TO THE WIRE WHILE INSIDE PATIENT. NO INJURY OCCURRED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911202 TURBO ELITE LASER ATHERECTOMY CATHETER CATHETER FOR CROSSING TOTAL OCCLUSIONS PDU SPECTRANETICS CORP 414-151 FAY20C16A 00813132024710

    Patients

    Seq Age Sex Outcome Treatment
    1