BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 11257094 · Received February 1, 2021

    Report

    Report Number
    9612164-2021-00416
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 15, 2021
    Report Date
    May 21, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    UDI-DI
    00643169986268
    PMA / PMN Number
    P140018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO USE VENASEAL OCCLUDING DEVICE DURING PROCEDURE TO TREAT EITHER GREAT SAPHENOUS VEIN (GSV). TRANSDUCER WAS USED FOR COMPRESSION. IFU WAS FOLLOWED. IT WAS REPORTED THAT PATIENT HAD GLUE EXTENSION FROM THE GSV 2-3CM INTO THE COMMON FEMORAL VEIN. DELIVERY CATHETER STARTING POSITION WAS 5.5CM FROM THE SFF AND IFU WAS FOLLOWED FOR THE ENTIRE PROCEDURE. PHYSICIAN COMPRESSED GSV NORTH/ABOVE THE CATHETER AND DID NOT LET UP PRESSURE FOR 3:00 MINUTE HOLD. AFTER INITIAL 3 MINUTES, THE SFJ WAS SCANNED AND FOUND GLUE EXTENDING INTO THE DEEP SYSTEM/COMMON FEMORAL VEIN. PROCEDURE WAS COMPLETED USING NORMAL TECHNIQUE AND NO MALFUNCTION SEEN WITH THE VENASEAL GUN. THE VEIN CLOSED. NO PATIENT INJURY REPORTED. THE PATIENT IS DOING FINE. PATIENT WAS SEEN IN FOLLOW UP AND THE GLUE IS IN THE SAME POSITION AS IT WAS POST PROCEDURE. NO CHANGES HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158121 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND VS-402 60270 00643169986268

    Patients

    Seq Age Sex Outcome Treatment
    1