BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR CX DETACHABLE

    MDR report key: 8921900 · Received August 22, 2019

    Report

    Report Number
    2032493-2019-00195
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 23, 2019
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00812636021065
    PMA / PMN Number
    K151358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUSHER, MICROCATHETER, AND INTRODUCER WERE RETURNED FOR EVALUATION. THE IMPLANT COIL WAS NOT RETURNED. THE PUSHER WAS BENT AT THE PROXIMAL SECTION, OR CONNECTOR SECTION. THE STRAIN RELIEF WAS FOLDED. THE RECEIVED MICROCATHETER WAS RECEIVED CUT. THE MICROCATHETER WAS TESTED USING X-RAY AND IT DID NOT CONTAIN THE IMPLANT COIL. THE MONOFILAMENT WAS BROKEN INSIDE OF THE PUSHER; THE MONOFILAMENT'S CONDITION CONFIRMS THAT THE UNIT WAS NOT DETACHED USING THE V-GRIP SYSTEM (CONTROLLER). THE REPORTED COMPLAINT IS CONFIRMED. THE PHYSICAL EVALUATION OF THE RETURNED DEVICE FOUND THE IMPLANT HAD SEPARATED FROM THE PUSHER. THE IMPLANT WAS NOT RETURNED FOR EVALUATION, BUT THE VISUAL ANALYSIS OF THE PUSHER MONOFILAMENT DETERMINED THAT THE IMPLANT SEPARATED DUE TO TENSILE FORCE RATHER THAN A THERMAL DETACHMENT USING THE DETACHMENT CONTROLLER. THE IMPLANT WAS NOT RETURNED, SO THE INVESTIGATION COULD NOT DETERMINE IF THE IMPLANT HAD ANY DAMAGE, DEFECTS, OR OTHER ANOMALIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THE PUSHER WAS FOUND TO BE BENT, WHICH IS INDICATIVE OF EXCESSIVE ADVANCEMENT FORCE BEING PLACED ON THE DEVICE. THE DAMAGES TO THE DEVICE INDICATE THE COIL EXPERIENCED RESISTANCE OR BECAME STUCK IN THE MICROCATHETER AND THEN EXPERIENCED RETRACTION FORCES THAT EXCEEDED THE STRENGTH OF THE ATTACHMENT MONOFILAMENT. THE RETURNED MICROCATHETER (NON-MICROVENTION PRODUCT) WAS RECEIVED CUT, BUT IT IS POSSIBLE THAT THE MICROCATHETER WAS DAMAGED AT THAT LOCATION PRIOR TO THE CUT; DAMAGE TO THE MICROCATHETER CAN CAUSE THE TYPES OF DAMAGES THAT WERE FOUND WITH THE RETURNED COIL.

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. THE INVESTIGATION IS UNDERWAY. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE OR DIFFICULT COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RETRACTION OF AN EMBOLIZATION COIL DURING POSITIONING, THE IMPLANT COIL DETACHED. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL INTO THE TREATMENT SITE, BUT THERE WAS SOMETHING BLOCKING ACCESS TO THE IMPLANT IN THE CATHETER. A SNARE WAS USED TO REMOVE THE BLOCKAGE FROM THE LUMEN, AND THEN THE IMPLANT COIL WAS PUSHED INTO POSITION. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716303 AZUR CX DETACHABLE EMBOLIZATION COIL KRD MICROVENTION, INC. 45-750824 18121254N 00812636021065

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR