BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 25334538 · Received May 29, 2026

    Report

    Report Number
    2429304-2026-00076
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 12, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN INITIAL IN-OFFICE ITIND REMOVAL PROCEDURE PERFORMED WITHOUT SEDATION, THE PHYSICIAN REPORTEDLY ATTEMPTED DEVICE REMOVAL USING A NAVIGATOR URETERAL SHEATH. DURING THE ATTEMPT, THE RETRIEVAL STRING REPORTEDLY BROKE AT THE HUB, PREVENTING THE SUCCESSFUL REMOVAL OF THE DEVICE. A SECOND REMOVAL ATTEMPT UTILIZING AN ACCESS SHEATH WAS UNSUCCESSFUL, RESULTING IN THE POSTPONEMENT OF THE PROCEDURE. THE FOLLOWING DAY, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE UNDER SEDATION, DURING WHICH THE DEVICE WAS SUCCESSFULLY REMOVED USING A THIRD-PARTY RIGID CYSTOSCOPE AND GRASPER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ITIND HUB APPEARED SOMEWHAT EMBEDDED IN THE ANTERIOR PROSTATIC URETHRA, WHICH MAY HAVE CONTRIBUTED TO THE INABILITY TO ENGAGE AND RETRIEVE THE DEVICE DURING THE INITIAL ATTEMPT. THE PHYSICIAN REPORTED THAT THE PATIENT OTHERWISE DID WELL AND DID NOT ANTICIPATE AN IMPACT ON THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440536 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE LTD. WA2ITA00 13032023-2 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1