BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXS VECTA 071 INTERMEDIATE CATHETER (132CM)

    MDR report key: 9351164 · Received November 20, 2019

    Report

    Report Number
    3008853977-2019-00068
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 31, 2019
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NRY
    UDI-DI
    07613327459234
    PMA / PMN Number
    K172167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE AND IT WAS OBSERVED THE CATHETER WAS STUCK IN THE NON-STRYKER DEVICE AND WAS STRETCHED. WHEN IT WAS REMOVED, IT WAS BROKEN. DIMENSIONAL INSPECTION NOT REQUIRED AS THE DEFECT WAS VISUALLY CONFIRMED. FUNCTIONAL COULD NOT BE PERFORMED BASED ON DAMAGE TO PRODUCT. THE DEVICE WAS STATED TO BE IN GOOD CONDITION AND WAS PREPARED ACCORDING TO THE DFU SPECIFICATIONS. THE REPORTED ISSUE IS COVERED IN THE DEVICE DIRECTIONS FOR USE. THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED EVENT WAS CONFIRMED. IT IS PROBABLE THAT THE DEVICE WAS DAMAGED DURING THE CLINICAL PROCEDURE DUE TO SOME PROCEDURAL/ANATOMICAL FACTORS ENCOUNTERED CAUSING THE AS REPORTED EVENT, THEREFORE ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO REPORTED ISSUE. THE AS REPORTED CATHETER SHAFT BREAK DURING USE CAN BE CONFIRMED. THE AS REPORTED/ AS ANALYZED CATHETER SHAFT BREAK DURING USE AS WELL AS THE AS ANALYZED CATHETER SHAFT STRETCHED WILL BE ASSIGNED PROCEDURAL FACTORS AS THESE DEFECTS APPEAR TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER AND DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL OR ANATOMICAL FACTORS DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE FIRST PASS WITH CATHETER WHILE ATTEMPTING TO DISCONNECT THE TUBING FROM CATHETER THE CATHETER BROKE AT THE HUB. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENTS MEDICAL CONDITION WAS GOOD. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE FIRST PASS WITH CATHETER WHILE ATTEMPTING TO DISCONNECT THE TUBING FROM CATHETER THE CATHETER BROKE AT THE HUB. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENTS MEDICAL CONDITION WAS GOOD. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144580 AXS VECTA 071 INTERMEDIATE CATHETER (132CM) CATHETER, THROMBUS RETRIEVER NRY STRYKER NEUROVASCULAR-CALIF UNKNOWN 07613327459234

    Patients

    Seq Age Sex Outcome Treatment
    1 ASPIRATION TUBING (UNKNOWN)