BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 9509182 · Received December 23, 2019

    Report

    Report Number
    9612164-2019-05286
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    December 16, 2019
    Report Date
    December 27, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POST PROCEDURE ULTRASOUND SCAN WAS CARRIED OUT 30 - 45 MINUTES POST-PROCEDURE. 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 VENASEAL OCCLUDING DEVICE DURING PROCEDURE TO TREAT 15CM OF THE GREAT SAPHENOUS VEIN (GSV). IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. A GUIDE WIRE WAS USED FOR THE INSERTION OF THE CATHETER. IT WAS REPORTED THAT THE BILATERAL VENASEAL SCHEDULED FOR THE PATIENT, TOR THE TREATMENT OF THE LEFT GSV WAS DONE WITH NO ISSUES OBSERVED. GLUE CATHETER WAS REMOVED FROM LEFT LEG, TIP WAS WIPED CLEAN WITH A CLEAN DRY GAUZE. SAME CATHETER WAS USED FOR RIGHT GSV. WHEN ADMINISTERING THE 1ST DOSE 6CM AWAY FROM THE SFJ, PLUNGER IN THE SYRINGE DID NOT MOVE, ALTHOUGH GUN LEAVER WAS PRESSED FIRMLY AND HELD FOR 3 SECS. COMPRESSION WAS MAINTAINED WITH AN ULTRASOUND TRANSDUCER. PHYSICIAN REPEATEDLY ADMINISTERED 2 MORE DOSES AT THE SAME SPOT BUT, PLUNGER DID NOT MOVE. A NEW KIT FROM THE SAME LOT WAS OPENED. THE PROCEDURE WAS COMPLETED WITH A GUN AND SYRINGE OF GLUE PER IFU. 30 - 35 MINUTES POST-PROCEDURE ULTRASOUND SCAN SHOWED THAT CFV NEAR THE SFJ WAS 20% OCCLUDED WITH 0.3MLS GLUE, ABOUT 1 CM LONG SEGMENT. THE PROCEDURE WAS CONVERTED FROM ENDO TO OPEN PROCEDURE TO REMOVE HARDENED GLUE FROM CFV NEAR THE SFJ. NO FURTHER PATIENT INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308322 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND SP-101 55676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention