BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXS CATALYST 5 - 058X115 (FDA)

    MDR report key: 7699905 · Received July 18, 2018

    Report

    Report Number
    3008881809-2018-00309
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    April 13, 2018
    Report Date
    July 18, 2018
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    DQY
    UDI-DI
    07613327012019
    PMA / PMN Number
    K151667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DAC SHAFT WAS BROKEN/ FRACTURED AT THE JUNCTION OF THE GRILAMID SLEEVE AND THE CATHETER SHAFT AT THE PROXIMAL END. THERE WERE NO ANOMALIES NOTED TO THE HOOP AND RETAINING CLIP. AS PER THE ADDITIONAL INFORMATION, THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT IS PROBABLE THAT THE DEVICE WAS DAMAGED AS A RESULT OF HANDLING OF THE DEVICE DURING REMOVAL OF THE DEVICE FROM ITS PACKAGING.

    Description of Event or Problem · 1

    THE REVIEW OF THE INVESTIGATION REVEALED THAT THE DISTAL ACCESS CATHETER (SUBJECT DEVICE) SHAFT WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540960 AXS CATALYST 5 - 058X115 (FDA) CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR CORK 19449133 07613327012019

    Patients

    Seq Age Sex Outcome Treatment
    1