BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER INTRODUCER SYSTEM

    MDR report key: 16690868 · Received April 6, 2023

    Report

    Report Number
    0001625425-2023-01015
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 6, 2023
    Report Date
    May 23, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    GCB
    UDI-DI
    00886333004515
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. AFTER THREE NOTIFICATIONS, THE SAMPLE HAS NOT BEEN RETURNED FOR REVIEW, HOWEVER, IMAGES WERE PROVIDED. A REVIEW OF THE PROVIDED IMAGES WAS FOUND TO BE CONSISTENT WITH THE REPORTED ISSUE. THEREFORE, THIS COMPLAINT WILL BE CONFIRMED. THE MOST PROBABLE CAUSE FOR THE REPORTED ISSUE WAS MOST LIKELY RELATED TO AN EVENT WITHIN THE USER ENVIRONMENT. POSSIBLY THE WIRE WAS PULLED BACK THROUGH THE NEEDLE AS THE IFU CAUTIONS AGAINST. THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING THIS ISSUE WITH THIS LOT NUMBER. SINCE THE REPORTED ISSUE WAS MOST LIKELY RELATED TO THE USER ENVIRONMENT AND NOT A MANUFACTURING ERROR, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

    Description of Event or Problem · 0

    DURING THE INSERTION OF THE DRAINAGE TUBE, THE GUIDE WIRE WAS STRIPPED AND LEFT IN THE PATIENT'S BODY, AND ADDITIONAL GUIDE WIRES WERE USED TO REMOVE IT.

    Description of Event or Problem · 0

    DURING THE INSERTION OF THE DRAINAGE TUBE, THE GUIDE WIRE WAS STRIPPED AND LEFT IN THE PATIENT'S BODY, AND ADDITIONAL GUIDE WIRES WERE USED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756245 SKATER INTRODUCER SYSTEM SKATER GCB ARGON MEDICAL DEVICES 651506300 11402341 00886333004515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R