BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 21123218 · Received January 10, 2025

    Report

    Report Number
    9612164-2025-00203
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 10, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    A PHYSICIAN USED A VENASEAL CLOSURE SYSTEM TO TREAT THE LEFT MID GREAT SAPHENOUS VEIN (GSV) IN A PATIENT. THERE WERE NO CHALLENGES OR DEVIATIONS RELATED TO LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE. THE CATHETER TIP WAS 5CM CAUDAL TO SFJ. THERE WAS COMPRESSION OF GSV. POST OP, IT WAS REPORTED THAT THE PATIENT IS HAVING SHARDS OF GLUE OUTSIDE THE VEIN PUSH TOWARDS AND THROUGH THE SKIN. THERE ARE NO KNOWN PATIENT ALLERGIES OR CO-MORBIDITIES. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. ISSUE IS STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380008 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male