BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENTSON STRAIGHT FIXED CORE (COATED) GUIDEWIRE

    MDR report key: 3902236 · Received June 24, 2014

    Report

    Report Number
    1319211-2014-00095
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQX
    PMA / PMN Number
    K850827
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. TO DATE THE DEVICE HAS YET TO BE RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. 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.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR A DRAINAGE INSERTION PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THE GUIDEWIRE USED HAD FRACTURE INSIDE OF THE PATIENT. THE FRACTURED PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368432 BENTSON STRAIGHT FIXED CORE (COATED) GUIDEWIRE GUIDEWIRE DQX ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention