BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS / MINI STICK MAX

    MDR report key: 8717611 · Received June 20, 2019

    Report

    Report Number
    1317056-2019-00080
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    April 1, 2019
    Report Date
    August 14, 2019
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DRE
    UDI-DI
    H965457561
    PMA / PMN Number
    K132713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS 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 JUNE 2019 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE MINI STICKS PRODUCT FAMILY AND THE FAILURE MODE "GUIDEWIRE FRACTURED/MIGRATED. " NO ADVERSE TREND WAS IDENTIFIED. AS THE GUIDEWIRE FROM THE REPORTED EVENT IS A PURCHASED DEVICE FOR ANGIODYNAMICS, IT WAS RETURNED TO THE SUPPLIER, HERAEUS MEDICAL COMPONENTS FOR EVALUATION AND COMPLETION OF A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). HERAEUS' REVIEW OF THEIR DEVICE HISTORY RECORDS CONFIRMED THAT ALL UNITS WERE PROPERLY ASSEMBLED AND INSPECTED AND WERE SENT WITHIN SPECIFICATION AND MET QUALITY REQUIREMENTS SUCCESSFULLY. THE RETURNED SAMPLE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION. AS THE REPORTED ISSUE HAS BEEN DETERMINED NOT TO BE THE RESULT OF A MANUFACTURING DEFECT, IT WAS LIKELY GENERATED DURING USE/IN THE FIELD. (B)(4).

    Additional Manufacturer Narrative · 1

    THE USED GUIDEWIRE WAS RETURNED TO ANGIODYNAMICS IN TWO PIECES. AS THIS COMPONENT IS PURCHASED BY ANGIODYNAMICS FROM HERAEUS MEDICAL COMPONENTS, IT HAS BEEN FORWARDED TO THEM, ALONG WITH A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST). UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED DURING ACCESS FOR AN ANGIOGRM THE GUIDEWIRE FROM A MINISTICK MAX BROKE OFF INTO THE RIGHT FEMORAL ARTERY. THE PHYSICIAN WAS ABLE TO REMOVE IT ALL IN ITS ENTIRETY WITH NO HARM TO THE PATIENT. THE GUIDEWIRE HAS BEEN RETURNED TO ANGIODYNAMICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511236 ANGIODYNAMICS / MINI STICK MAX VESSEL DILATORY FOR PERCUTANEOUS CATHETERIZATION DRE ANGIODYNAMICS 5440444 H965457561

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention