BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET

    MDR report key: 16768138 · Received April 19, 2023

    Report

    Report Number
    16768138
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    February 10, 2023
    Report Date
    April 12, 2023
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PLEURX ROCKET CATHETER STENT FROM "ROCKET IPC INSERTION SET" BECAME STUCK UPON REMOVAL FROM RIGHT CHEST DURING PROCEDURE. STENT/WIRE RETRIEVED BY PULLING AND WAS NOTABLY STRETCHED AND ELONGATED AT THE TIP UPON REMOVAL. XRAY IMAGING WAS DONE AT END OF PROCEDURE TO CONFIRM NO PRESENCE OF FOREIGN BODY WAS RETAINED, XRAY BELIEVES THERE MIGHT BE A SMALL FRAGMENT RETAINED. DR. HAS ORDERED A CATSCAN TO CONFIRM. CT NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520123 ROCKET APPARATUS, SUCTION, PATIENT CARE DWM ROCKET MEDICAL PLC R51400-16-00 498411

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA Male