BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 24526646 · Received March 5, 2026

    Report

    Report Number
    2429304-2026-00030
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 5, 2026
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ITIND REMOVAL PROCEDURE UNDER SEDATION IN A 60-YEAR-OLD MALE, THE SUTURE STRING BROKE HALFWAY DOWN SO SOME OF THE STRING WAS STILL OUTSIDE THE PATIENT. AN ATTEMPT TO ATTACH THE STRING TO A 0 EITHIBOND FAILED, SO ANOTHER ATTEMPT WAS MADE TO ATTACH TO A REMOVAL SNARE WHICH ALSO FAILED. THUS, THE PROCEDURE WAS CONVERTED TO AN OPERATION ROOM PROCEDURE TO REMOVE IT WITH A CYSTOSCOPE UNDER SEDATION. PATIENT WAS REPORTED TO HAVE MORE DISCOMFORT THAN ORDINARY DUE TO THE MULTIPLE ATTEMPTS, BUT NO PERSISTENT OR LONG-TERM NEGATIVE EFFECTS WERE REPORTED THE PROCEDURE WAS DELAYED BY GREATER THAN 30 MINUTES. THE INITIAL REMOVAL ATTEMPT WAS APPROXIMATELY 15 MINUTES, HOWEVER, IT TOOK ABOUT AN HOUR TO OBTAIN ANESTHESIA CONSENT AND TO TRANSITION THE PATIENT INTO THE OR SETTING. ONCE IN THE OR THE SUCCESSFUL REMOVAL OF THE ITIND WAS LESS THAN 10 MINUTES. THERE WERE NO FURTHER REPORTS OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376139 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE LTD. WA2ITA00 NI 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention