BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD SNARE RETRIEVAL KIT

    MDR report key: 19120369 · Received April 16, 2024

    Report

    Report Number
    3008988055-2024-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 16, 2024
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    MMX
    UDI-DI
    00857834006551
    PMA / PMN Number
    K152560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY. DEVICE WAS DISCARDED BY USER AND IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    ROUTINELY DISINFECT THE SKIN AND SPREAD STERILE DRAPE. AFTER SUCCESSFUL LOCAL ANESTHESIA WITH DOCAINE, PUNCTURE THE RIGHT JUGULAR VEIN USING THE SELDINGER METHOD AND INSERT. CONTRAST CATHETER, PERFORM INFERIOR VENA CAVA ANGIOGRAPHY, SEE THE INFERIOR VENA CAVA. THE VEINS ARE UNOBSTRUCTED, THE FILTER IS IN GOOD POSITION, AND THERE ARE NO THROMBI ATTACHED. INSTALL, REPLACE THE RECOVERY SHEATH, POSITION UNDER FLUOROSCOPY, AND APPLY THE CATCHER SUCCESSFULLY CAPTURED THE RECOVERY HOOK AND PUSHED IT FORWARD FOR RECOVERY SHEATH, RETRACT THE FILTER INTO THE SHEATH, AND RECYCLE THE FILTER SMOOTHLY AFTER WITHDRAWING, THE MARKING TAPE WAS FOUND TO HAVE FALLEN OFF, CAUSING ANOTHER THE IMAGE SHOWED THAT THE MARKER BAND WAS LOST TO THE HEART, AND DURING THE OPERATION BLEEDING IS ABOUT 10ML. PRESS THE PUNCTURE POINT FOR 15 MINUTES AFTER SURGERY. AFTERWARDS, THE PUNCTURE POINT WAS BANDAGED WITH PRESSURE. THE OPERATION WENT SMOOTHLY. THE PATIENT FELT NO DISCOMFORT AND RETURNED TO THE WARD SAFELY. SATURATIONDEGREE 99%, R 19 TIMES, MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925885 BARD SNARE RETRIEVAL KIT DEVICE, PERCUTANEOUS RETRIEVAL MMX HERAEUS MEDICAL COMPONENTS LLC SP-4094-002 9015010308 00857834006551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other