BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET

    MDR report key: 24429382 · Received February 24, 2026

    Report

    Report Number
    3002808026-2026-00004
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFORMATION PROVIDED BY CUSTOMER: SEVERAL PULMONOLOGISTS PERFORMED THERAPEUTIC PLEURAL TAPS USING THE ROCKET MEDICAL DEVICE IN THE DEPARTMENT. IMMEDIATELY AFTER INSERTING THE CATHETER INTO THE PLEURAL SPACE AND REMOVING THE GUIDEWIRE, THE INTERFACE BROKE, PREVENTING THE PATIENT FROM ATTACHING THE DEVICE TO SEAL THE PUNCTURE. THE DRAINAGE CONTINUED AND ENDED WITHOUT CONSEQUENCE, BUT THE PATIENT COULD HAVE EXPERIENCED A PNEUMOTHORAX AND/OR RESPIRATORY FAILURE. THIS SITUATION OCCURRED THREE TIMES. THE PHYSICIAN APPLIED THEIR FINGER TO THE OPENING LEFT BY THE DEVICE'S BREAK TO ENSURE A SEAL (HYGIENE PROTOCOLS WERE FOLLOWED BY WEARING STERILE GLOVES). DRAINAGE CONTINUED, BUT UNDER LESS THAN OPTIMAL SAFETY CONDITIONS. ANOTHER PHYSICIAN CHOSE TO IMMEDIATELY REMOVE THE DEVICE AND REPLACE IT WITH ANOTHER, CAUSING ADDITIONAL PAIN FOR THE PATIENT. CHECK WITH THE TECHNICIAN AGAIN, AS THIS IS A RECURRING PROBLEM WITH THIS DEVICE. IT HAPPENS ONCE OR SEVERAL TIMES A MONTH. IT AFFECTS ONE OR MORE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487662 ROCKET ROCKET THORACENTESIS CATHETER 8FG GBX ROCKET MEDICAL PLC R51551-08-00 504575 AND 504351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other