BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CROSS CATHETER 0.018 WIRE

    MDR report key: 12016667 · Received June 16, 2021

    Report

    Report Number
    MW5101949
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 15, 2021
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING BALLOON ANGIOPLASTY ONE WIRE TIP WAS DAMAGED AND THE TIP STAYED IN THE ILIAC ARTERY. THE TIP WAS RETRIEVED AFTER MAKING A SMALL INCISION. FDA SAFETY REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902807 QUICK CROSS CATHETER 0.018 WIRE CATHETER, PERCUTANEOUS DQY SPECTRANETICS CORP. 518-037 FQQ21B11A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR