BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOCATH ET CATHETERS

    MDR report key: 25028497 · Received April 29, 2026

    Report

    Report Number
    3002808026-2026-00006
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    MQF
    PMA / PMN Number
    K994327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADVERSE EFFECT ON PATIENTS HAS BEEN IDENTIFIED IN RELATION TO THE REPORTED EVENT, AND NO HARM HAS BEEN OBSERVED TO DATE. HOWEVER, THE INCIDENT IS BEING REPORTED ON A PRECAUTIONARY BASIS DUE TO THE THEORETICAL AND VERY REMOTE POSSIBILITY THAT RETAINED ECHOBAND MATERIAL WITHIN THE UTERINE CAVITY COULD CONTRIBUTE TO THE DEVELOPMENT OF ABDOMINAL OR INTRAUTERINE ADHESIONS. WHILE THERE IS NO CLINICAL EVIDENCE FROM THE CURRENT CASE OR POST-MARKET DATA TO SUGGEST THAT SUCH AN OUTCOME HAS OCCURRED OR IS LIKELY TO OCCUR, THIS POTENTIAL RISK IS ACKNOWLEDGED WITHIN A CONSERVATIVE SAFETY ASSESSMENT FRAMEWORK AND WARRANTS CONTINUED VIGILANCE AND REPORTING IN LINE WITH APPLICABLE REGULATORY EXPECTATIONS.

    Description of Event or Problem · 0

    EXACT WORDING OF COMPLAINT RECEIVED FROM CUSTOMER: 'TWO MORE CATHETER DEFECTS. THE ISSUE NOW IS THE ECHOGENIC METAL TIP BECOMING DISLODGED AND MOVING OUT OF PLACE, OR WORSE FALLING OUT. THIS HAPPENED WHILE A CATHETER WAS PLACED INSIDE THE RECIPIENT (WHICH TOOK A LONG TIME TO EXTRACT AND LED TO A REFREEZE OF AN EMBRYO), AS WELL AS THE TRANSFER WHEN FLUSHING THE CATHETER.' ROCKET MEDICAL EXPLANATION: WE ARE UNABLE TO OBTAIN THE DEVICE BACK. THE IMPLICATED DEVICES ARE EMBRYO TRANSFER CATHETERS. THE CATHETERS HAVE AN ECHOGENIC BAND (ECHOBAND) LOCATED ON THE DISTAL TIP. TO ENABLE VISUALIZATION OF THE DEVICE TO AID EMBRYO PLACEMENT VIA ULTRASOUND. IT WAS NOT POSSIBLE TO HAVE THE DEVICES RETURNED FOR FURTHER ANALYSIS HOWEVER, FROM THE USER REPORT IT HAS BEEN CONFIRMED THAT THERE IS A REMOTE POSSIBILITY OF ECHOBAND DETACHMENT FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537607 ECHOCATH ET CATHETERS EMBRYON ECHOCATH ET CATHETER 18CM MQF ROCKET MEDICAL PLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O