BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGSURGI

    MDR report key: 8724760 · Received June 21, 2019

    Report

    Report Number
    1219930-2019-03653
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    June 21, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE COMPARISON OF CYANOACRYLATE EMBOLIZATION AND RADIOFREQUENCY ABLATION FOR THE TREATMENT OF VARICOSE VEINS SOURCE PHLEBOLOGY, VOLUME 34(4) 278¿283 DATE OF PUBLICATION: 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY, A REVIEW OF CLINICAL OUTCOMES OF VARICOSE VEIN PATIENTS TREATED WITH RADIOFREQUENCY ABLATION (RFA) WAS PERFORMED. THE MOST COMMON COMPLICATION WAS SUPERFICIAL PHLEBITIS, WHICH WAS NOTED IN 16% OF RFA PATIENTS. FIVE PATIENTS IN THE RFA GROUP PERSISTED TO HAVE SOME LEVEL OF PARESTHESIA AFTER THE MID-TERM FOLLOW-UP, ALTHOUGH NONE OF IT WAS DEBILITATING. ONE CASE OF THROMBUS EXTENSION INTO THE DEEP SYSTEM WAS NOTED IN THE RFA TREATMENT GROUP AT FOLLOW-UP ULTRASOUND. ONE PATIENT IN THE RFA GROUP HAD LEVEL 3 CLOSURE BASED ON THE PREVIOUSLY PROPOSED CLASSIFICATION WITH THROMBUS FLUSH WITH THE FEMORAL VEIN THAT WAS TREATED WITH THREE WEEKS OF RIVAROXABAN. ONE PATIENT IN THE RFA GROUP HAD DELAYED WOUND HEALING AT THE ACCESS SITE THAT REQUIRED OUTPATIENT DEBRIDEMENT AND CONTINUED WOUND CARE. THESE WOUNDS EVENTUALLY HEALED UP AT THE SIX WEEKS FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518328 INSIGSURGI INSIGSURGI GEI COVIDIEN LP LLC NORTH HAVEN VPACK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other