BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENACURE NEVERTOUCH DIT

    MDR report key: 3553033 · Received December 19, 2013

    Report

    Report Number
    1319211-2013-00165
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    November 12, 2013
    Report Date
    December 5, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS NOT AVAILABLE TO BE RETURNED TO THE MFR FOR EVALUATION AS IT WAS DISPOSED OF BY THE USER. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF DILATOR/SHEATH IS NOT STIFF ENOUGH CANNOT BE CONFIRMED SINCE NO PRODUCT WAS RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AS REPORTED, THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2013, PATIENT OF UNK AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TREATING PHYSICIAN EXPERIENCED DIFFICULTY INTERFACING THE ACCESS DILATOR AND SHEATH. THE PATIENT DEVELOPED PHLEBITIS DUE TO THE IRRITATION TO THE TISSUE AT THE SITE OF THE DILATOR/SHEATH ISSUE. THE PATIENT WAS TREATED WITH LIDOCAINE. NO ADDITIONAL HOSPITALIZATION WAS REQUIRED DUE TO THIS EVENT AS THE PHLEBITIS DISSOLVED AFTER TREATMENT. THE REPORTED DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MFR FOR EVALUATION AS IT WAS DISPOSED OF BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665779 VENACURE NEVERTOUCH DIT ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention