BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET

    MDR report key: 3918817 · Received June 25, 2014

    Report

    Report Number
    1820334-2014-00274
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COOK UROLOGICAL INC.
    Product Code
    MQF
    UDI-DI
    00827002303997
    PMA / PMN Number
    K914150
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING A MOCK EMBRYO TRANSFER PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE INNER CATHETER AND IT GOT STUCK ON THE OUTER CATHETER. WHEN THE PHYSICIAN REMOVED THE SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER IT WAS NOTED THAT THE ECHO TIP BAND WAS NOT THERE. AN ULTRASOUND WAS DONE AND THE TIP WAS FOUND IN THE PATIENT. THE PATIENT HAD A SEPARATED BAND RETRIEVED VIA HYSTEROSCOPY ON (B)(6) 2014. IT WAS INDICATED THAT THEY HAD TO GO IN WITH A RIGID SCOPE TO REMOVE THE BAND AS IT WAS DIFFICULT TO RETRIEVE. THIS WAS THE SECOND IVF PROCEDURE FOR THE PATIENT. THERE WAS NO SHARP CERVICAL ANGLE. NO HARM WAS NOTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369705 SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET MQF: CATHETER, ASSISTED REPRODUCTION MQF COOK UROLOGICAL INC. U2479311 00827002303997

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT PRO Required Intervention