BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBRYON ECHOCATH ET CATHETER

    MDR report key: 25331199 · Received May 29, 2026

    Report

    Report Number
    3002808026-2026-00007
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 19, 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICES NOT RETURNED. DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    EXACT WORDING FROM COMPLAINT RECEIVED FROM CUSTOMER: OUR CLINIC NEEDS TO REPORT A DEVICE MALFUNCTION WITH THE CATHETER REFERENCED IN THE SUBJECT LINE. WE HAD AN INSTANCE IN WHICH THE CATHETER WAS USED FOR EMBRYO TRANSFER, AND THE ECHOGENIC RING DISLODGED FROM THE DEVICE DURING THE TRANSFER AND DAYS LATER, THE PATIENT RECOVERED THE RING FROM HER VAGINA. LUCKILY, THE MALFUNCTION DID NOT HAVE ANY APPARENT ADVERSE EFFECT ON THE PROCEDURE. UPDATE: WE PERFORMED AN EMBRYO TRANSFER TODAY, STARTING WITH A TRIAL CATHETER R57631-EC-23, LOT: 504769. AFTER PLACEMENT OF THE OUTER CATHETER AN RETRACTION OF THE INNER CATHETER, WE FOUND THAT THE ECHOGENIC RING WAS DISLODGED, AND VISIBLE IN THE PATIENT'S CERVIX BY ABDOMINAL ULTRASOUND. BASED ON THIS EVIDENCE, THE DEFECT MAY OR MAY NOT BE LIMITED TO TRIAL CATHETER R57631-EC-23, LOT: 504769, AND PERHAPS NOT THE EMBRYO TRANSFER CATHETER. ROCKET MEDICAL EXPLANATION: TWO SEPARATE INCIDENTS REPORTED R57630-EC-23 IS THE EMBRYO CATHETER AND R57631 -EC-23 IS THE TRIAL CATHETER BOTH CONTAIN THE ECHOGENIC RING WHICH HAS FOUND TO HAVE BEEN DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226103 EMBRYON ECHOCATH ET CATHETER EMBRYON ECHOCATH ET CATHETER 23CM, EMBRYON ECHOCATH TRIAL TRANSFER CATHETER 23CM MQF ROCKET MEDICAL PLC 504768 AND 504769

    Patients

    Seq Age Sex Outcome Treatment
    1