BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS / SMART PORT

    MDR report key: 6677939 · Received June 29, 2017

    Report

    Report Number
    1056436-2017-00093
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    June 7, 2017
    Report Date
    August 17, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT HAS BEEN INDICATED THAT NO SAMPLE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION, THE INVESTIGATION INTO THIS EVENT IS ON-GOING, WITH ANGIODYNAMICS ATTEMPTING TO OBTAIN ADDITIONAL EVENT DETAILS FROM THE END USER HOSPITAL. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED SINCE THERE WAS NO REPORTED LOT #. A SHIPPING HISTORY LOT REVIEW WAS ALSO NOT PERFORMED SINCE ITEM # IS UNKNOWN. THE JUNE 2017 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE SMARTPORT PRODUCT FAMILY AND THE FAILURE MODE "CATHETER FRACTURED. " NO ADVERSE TREND WAS IDENTIFIED. DESPITE MULTIPLE GOOD FAITH EFFORTS ON THE PART OF ANGIODYNAMICS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT, NONE WAS OBTAINED. WITHOUT RECEIVING A DEVICE FOR EVALUATION, THE COMPLAINT IS UNABLE TO BE CONFIRMED, AND THE ROOT CAUSE UNABLE TO BE DETERMINED. THE DIRECTIONS FOR USE PROVIDED WITH THE SMART PORT CONTAIN GUIDANCE ON PORT PLACEMENT, MAINTENANCE, AND REMOVAL. POTENTIAL COMPLICATIONS SUCH AS CATHETER FRAGMENTATION AND CATHETER PINCH-OFF ARE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, WHEN ATTEMPTING TO REMOVE A PORT WHICH HAD BEEN IMPLANTED ON (B)(6) 2016, THE CATHETER HAD BECOME BRITTLE, DIFFICULT TO REMOVE, AND FRACTURED. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL DETAILS OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458143 ANGIODYNAMICS / SMART PORT PORT & CATHETER LJT ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention