BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEROSAFUSE IMPLANTABLE FASTENER KIT

    MDR report key: 20309767 · Received September 26, 2024

    Report

    Report Number
    1721504-2024-00070
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 6, 2024
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    ODE
    UDI-DI
    00810275014011
    PMA / PMN Number
    172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT A PATIENT RETURNED WITH A STRICTURE APPROXIMATELY 30 DAYS POST-CTIF PROCEDURE. THE PRIMARY CTIF PROCEDURE OCCURRED ON (B)(6) 2024. THE PATIENT RETURNED TO THE HOSPITAL (B)(6) 2024 AND WAS EXPERIENCING DYSPHAGIA, VOMITING, AND NAUSEA AT THE TIME. AN X-RAY DEMONSTRATED SOME MILD NARROWING OF THE GE JUNCTION. AN EGD WAS PERFORMED ON (B)(6) 2024 AND DEMONSTRATED SEVERE STENOSIS 4CM IN LENGTH. THE PHYSICIAN STATES THAT HE WAS UNABLE TO PASS A SCOPE INTO THE PATIENT'S STOMACH DURING THE EGD PROCEDURE UNTIL AFTER A 15MM BALLOON DILATION ATTEMPT. THE PATIENT HAS BEEN DILATED WITH BOUGIE 3 TIMES SINCE THE ORIGINAL CTIF PROCEDURE. THE PHYSICIAN IDENTIFIED SEVERAL LONG TIF FASTENERS EXTRUDING OUT INTO THE ESOPHAGEAL JUNCTION JUST ABOVE THE EGJ. THE PROTRUDING FASTENERS WERE LIKELY THE CAUSE OF THE ESOPHAGEAL STRICTURE IDENTIFIED WITHIN THIS PATIENT. THE PHYSICIAN USED ENDOSCOPIC SCISSORS TO CUT 4 FASTENERS THAT WERE PROTRUDING INTO THE LUMEN OF THE ESOPHAGUS AND STATED THAT IT LOOKED LIKE THE ESOPHAGUS HAD RELAXED UP A BIT. THE PHYSICIAN INJECTED BOTOX. PLANS TO INSERT PEG TUBE IN 2 WEEKS FOR NUTRITION IF ALL INTERVENTIONS FAIL. THE PHYSICIAN STATES THAT ALL INTERVENTIONS WERE NECESSARY TO PREVENT IMPAIRMENT. THE ESOPHYX DEVICE USED DURING THE TIF PROCEDURE OPERATED AS INTENDED WITH NO MALFUNCTIONS TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263451 SEROSAFUSE IMPLANTABLE FASTENER KIT ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) ODE MERIT MEDICAL SYSTEMS INC. 00810275014011

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R