BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 8878216 · Received August 9, 2019

    Report

    Report Number
    9612164-2019-03309
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    August 7, 2019
    Report Date
    October 29, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT NOTING IMPROVEMENT IN SYMPTOMS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE VENASEAL KIT WAS RETURNED. COMPONENTS RETURNED ARE : A DISPENSER GUN, A CATHETER, DILATOR AND BLUE INTRODUCER. THE BLUE INTRODUCER WAS EXAMINED. NO ABNORMALITIES WERE NOTED ON THE CATHETER SHAFT. THE BLUE INTRODUCER WAS UNABLE TO BE FLUSHED. THE BLUE INTRODUCER WAS SKIVED, AND IT WAS OBSERVED DRIED ADHESIVE WITHIN THE INTRODUCER SHEATH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE CATHETER TIP WAS 5CM CAUDAL TO THE SAPHENO FEMORAL JUNCTION (SFJ) PRIOR TO DELIVERY OF ADHESIVE. COMPRESSION WAS USED. TWO-DAY ULTRASOUND HAS CONFIRMED THE VEIN HAS CLOSED AND THERE IS GLUE EVIDENT IN THE VEIN. NO ADDITIONAL TREATMENT REQUIRED. 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 USED A VENASEAL KIT FOR TREATMENT OF THE PATIENT¿S GREAT SAPHENOUS VEIN (GSV). IFU WAS FOLLOWED DURING PREP/PROCEDURE. A G UIDERWIRE WAS USED FOR INSERTION OF THE CATHETER. IT IS REPORTED THE PHYSICIAN WAS UNABLE TO PASS THE VENASEAL DELIVERY CATHETER THROUGH BLUE VENASEAL SHEATH. IT WAS DECIDED TO FOREGO THE BLUE SHEATH AND ACCESS VESSEL DIRECTLY WITH WHITE VENASEAL DELIVERY CATHETER WHICH WAS SUCCESSFUL. IT WAS NOT POSSIBLE TO PASS ANYTHING (WIRE, DILATOR, SALINE, FLUSH) THROUGH BLUE SHEATH EVEN ON REMOVAL. COMPLETED VENASEAL PROCEDURE IN USUAL MANNER FOLLOWING IFU WITH APPROXIMATELY 8 SEGMENTS TREATED ONLY TO NOTE ONCE WHITE VENASEAL CATHETER WAS WITHDRAWN THAT WHITE CATHETER WAS NOT DELIVERING ADHESIVE APPROPRIATELY. IT IS SUSPECTED THE INABILITY TO DELIVER THE WHITE CATHETER THROUGH BLUE SHEATH INITIALLY CAUSED THE VENASEAL TO COME INTO CONTACT WITH FLUIDS RESULTING IN GLUE POLYMERIZATION THUS NOT ALLOWING DELIVERY OF ADHESIVE FROM WHITE CATHETER APPROPRIATELY. AWAITING RESULT OF 2 DAY POST PROCEDURAL ULTRASOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673005 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND 53170

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR