BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 6051878 · Received October 24, 2016

    Report

    Report Number
    1317056-2016-00158
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 29, 2016
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OEZ
    UDI-DI
    H965652001911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBER WAS PROVIDED, A SHIP HISTORY REPORT (SHR) WAS GENERATED FOR ITEM NUMBER H965652001911 IN ORDER TO DETERMINE THE LAST THREE LOTS SHIPPED TO THE REPORTING HOSPITAL IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. THE DEVICE HISTORY RECORDS FOR THE LOTS OBTAINED THROUGH THE SHR WERE REVIEWED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SEPTEMBER 2016 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE CONVENIENCE KITS PRODUCT FAMILY AND THE FAILURE MODE, "AIR INJECTED. " NO ADVERSE TRENDS WERE IDENTIFIED. THE REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED; NO SAMPLE WAS RETURNED. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. POSSIBLE ROOT CAUSE MAY BE THAT THE END USER DID NOT ADEQUATELY SECURE CONNECTIONS BETWEEN THE MANIFOLD AND COMPONENTS OR THE DEVICE THEY WERE CONNECTING TO WERE NOT "FINGER TIGHTENED" PRIOR TO USE AS IT IS STATED IN THE DFU PROVIDED TO THE END USER IN THE REPORTED KIT. THE DFU CONTAINS THE FOLLOWING STATEMENTS, "ENSURE THAT YOU ARE MAKING SECURE CONNECTIONS WHEN USING THIS DEVICE TO PREVENT THE INTRODUCTION OF AIR INTO THE SYSTEM THAT COULD RESULT IN EMBOLISM AND IN RARE INSTANCES OF DEATH. ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR THAT COULD RESULT IN EMBOLISM AND OR EXPOSURE TO BIOHAZARDS. EXAMINE PRODUCT CAREFULLY FOR ENTRAPPED AIR AND FULLY DEBUBBLE PRIOR TO INJECTION TO MINIMIZE THE POTENTIAL FOR EMBOLISM AND IN RARE INSTANCES DEATH." (B)(4). DEVICE DISCARDED AT HOSPITAL.

    Description of Event or Problem · 1

    AS REPORTED BY CATH LAB MANAGER, DURING USE OF AN ANGIODYNAMICS' CONVENIENCE KIT IN A HEART CATHETERIZATION PROCEDURE, A PATIENT WAS THOUGHT TO HAVE HAD AIR INJECTED INTO ONE OF THEIR CORONARY ARTERIES. THE PHYSICIAN PERCEIVED THAT AIR CAME FROM ONE OF THE LINES CONNECTED TO THE MANIFOLD. THE REPORT CONCLUDED THAT THE PATIENT " IS AND WAS COMPLETELY STABLE." THE USED PRODUCT WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702950 ANGIODYNAMICS CARDIOVASCULAR PROCEDURE KIT OEZ ANGIODYNAMICS H965652001911

    Patients

    Seq Age Sex Outcome Treatment
    1 Other