BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS

    MDR report key: 18283636 · Received December 7, 2023

    Report

    Report Number
    3006722112-0230-00232
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    June 27, 2022
    Report Date
    July 25, 2023
    Manufacturer
    APOLLO ENDOSURGERY, INC
    Product Code
    OCW
    UDI-DI
    10811955020763
    PMA / PMN Number
    K201808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINED MEDWATCH SUBMITTED TO THE FDA ON 07/DEC/2023. CLINICAL STUDY: 01 - 016. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS FOR USE (IFU) ADDRESSED THE KNOWN AND POTENTIAL EVENTS OF PREMATURE SEPARATION OF TACK AS FOLLOWS: THE X-TACK¿ SYSTEM IS INTENDED FOR APPROXIMATION OF SOFT TISSUE IN MINIMALLY INVASIVE GASTROENTEROLOGY PROCEDURES (E.G. CLOSURE AND HEALING OF ESD/EMR SITES, AND CLOSING OF FISTULA, PERFORATION OR LEAKS). PRECAUTIONS THE SYSTEM MAY ONLY BE USED IF PURCHASED FROM APOLLO ENDOSURGERY, INC. OR ONE OF ITS AUTHORIZED AGENTS. ADVANCE DEVICE CATHETER AND PUSH HELIX TACK AGAINST TISSUE. CAUTION: ENSURE THE HANDLE IS IN RESET. POSITION PRIOR TO DRIVING HELIX TACK. NOTE: DO NOT RETRACT DEVICE CATHETER FROM. THE WORKING CHANNEL WHILST A HELIX TACK IS INSTALLED; THIS COULD LEAD TO DEVICE DAMAGE OR INADVERTENT DETACHMENT. ADDITIONAL INFORMATION: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. DHR REVIEW WAS COMPLETED FOR LOT NUMBER, AF04884. THE SUBJECT PRODUCT MET ALL SPECIFICATIONS AND REQUIREMENTS IN EFFECT AT THE TIME OF MANUFACTURE. THERE WAS ONE OTHER COMPLAINT IN THE APOLLO DATABASE AGAINST THIS LOT NUMBER, AF04884. DEVICE EVALUATION SUMMARY: ASSESSMENT OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT POSSIBLE, AND IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 0

    PREMATURE OF TRACK NOT USED. INADEQUATE ANCHORING OF X-TACK CONSTRUCTS. OVESCO 11/6T, 1 CLIP(COMPETITORS DEVICE) USED IN THE CASE TO CLOSE THE PERFORATION OF THE ESOPHAGUS. MUCOSAL DEFECT CLOSURE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212966 X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS OCW APOLLO ENDOSURGERY, INC XTACK-160-H AF04884 10811955020763

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention