BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 8361226 · Received February 22, 2019

    Report

    Report Number
    9612164-2019-00604
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    February 7, 2019
    Report Date
    May 23, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE COMPONENT BLUE INTRODUCER WAS RETURNED LOOSELY IN A ZIP BAG. NO OTHER COMPONENTS FROM THE VENASEAL KIT WERE RECEIVED FOR EVALUATION. THE COMPONENT WAS REMOVED FROM THE PACKAGING FOR FURTHER INSPECTION. VISUAL INSPECTION OF BLUE INTRODUCER REVEALED THE DISTAL WAS DAMAGED. THERE IS EVIDENCE OF A TEAR OF THE DISTAL TIP IMAGE REVIEW: ONE IMAGE WAS RECEIVED FROM THE CUSTOMER. PER THE IMAGE, A DAMAGE WAS OBSERVED ON THE DISTAL TIP OF THE BLUE INTRODUCER. A DILATOR AND GUIDEWIRE WERE INSERTED INTO THE BLUE INTRODUCER. THE REPORTED EVENT WAS CONFIRMED BASED ON THE IMAGE RECEIVED. PER THE REPORTED EVENT, THE BLUE SHEATH FANNED OUT BUT THAT THIS WAS ONLY RECOGNIZED AFTER THE PROCEDURE. IT IS UNKNOWN WHAT MAY HAVE CAUSED THE REPORTED DAMAGE. THE DEVICE WAS RETURNED TO ANALYSIS LAB TO PERFORM ADDITIONAL ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE VENASEAL TO TREAT ONE SEGMENT OF THE GREAT SAPHANEOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU WAS FOLLOWED AND A GUIDEWIRE WAS USED. LOCAL ANAESTHESIA AND TRANSDUCER COMPRESSION WAS USED AND THE VEIN SUCCESSFULLY CLOSED. A VEIN FLOW NEEDLE WAS USED TO PUNCTURE THE SKIN AND A STITCH INCISION WAS MADE. IT WAS REPORTED THAT WHILE ACCESSING THE VEIN, THE BLUE SHEATH FANNED OUT BUT THAT THIS WAS ONLY RECOGNISED AFTER THE PROCEDURE. ANOTHER PRODUCT WAS USED FOR TREATING THE PATIENT¿S SECOND LEG. THE PATIENT FELT SOME PAIN DURING POSITIONING OF THE SHEATH TO THE SFJ. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153984 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND 53077

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR