BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEROSAFUSE IMPLANTABLE FASTENER KIT

    MDR report key: 20616268 · Received November 6, 2024

    Report

    Report Number
    1721504-2024-00074
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 14, 2024
    Report Date
    October 16, 2024
    Manufacturer
    MERIT MEDICAL SYSTEMS INC
    Product Code
    ODE
    UDI-DI
    00810275014011
    PMA / PMN Number
    K240879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS DISCARDED AT THE ACCOUNT. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING A HIATAL HERNIA [HH] REPAIR FOLLOWED BY A TRANSORAL INTRAGASTRIC FUNDOPLICATION [TIF]. DURING THE HHR PROCEDURE, THE PHYSICIAN DILATED THE PATIENT USING AN OVER-THE-WIRE DILATOR [60F] DEVICE, AND WHILE NO OBVIOUS RESISTANCE WAS NOTED, UPON INSPECTION BY THE ENDOSCOPE, THERE WAS TEARING NOTED IN THE ESOPHAGUS CAUSED BY THE INFLATION BALLOON. IT WAS NOT DEEMED TO BE SIGNIFICANT ENOUGH TO ABORT THE TIF PROCEDURE HOWEVER THE TEARING WAS OBSERVED THROUGHOUT A SIGNIFICANT PORTION OF THE LOWER ESOPHAGUS. THE TIF PROCEDURE WAS COMPLETED WITH 4 FIRINGS IN THE POSTERIOR ASPECT, 3 FIRINGS IN THE ANTERIOR, AND 3 FIRINGS IN THE GREATER CURVE AREA TO COMPLETE A 285° FUNDIPLICATION. NO PROBLEMS/ISSUES WERE NOTED DURING THE TIF PROCEDURE. POST-TIF PROCEDURE THE PHYSICIAN ORDERED AN EGD. THE PHYSICIAN NOTED A SUSPICIOUS AREA TOWARD THE POSTERIOR ASPECT OF THE REPAIRED VALVE. LOOKING AT THE INSIDE VIEW OF THE GEJ, THE SUSPICIOUS AREA COULD BE A PERFORATION. THE PHYSICIAN CONFIRMED THE PERFORATION AND PLACED A CLIP IN THE SUSPECTED AREA ALONG WITH FOUR ADDITIONAL CLIPS THAT WERE PLACED TO ADDRESS THE PERFORATION/TEARING OF THE GEJ. THE PATIENT WAS STENTED AND IS DOING WELL. NO EVIDENCE OF A DEVICE MALFUNCTION. THE PATIENT WAS KEPT OVERNIGHT FOR CONTINUED OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132872 SEROSAFUSE IMPLANTABLE FASTENER KIT ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) ODE MERIT MEDICAL SYSTEMS INC 403721 00810275014011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R