BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR 18 HYDROCOIL DETACHABLE

    MDR report key: 17784728 · Received September 20, 2023

    Report

    Report Number
    2032493-2023-00950
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 29, 2023
    Report Date
    December 4, 2023
    Manufacturer
    MICROVENTION, INC
    Product Code
    KRD
    PMA / PMN Number
    K120630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ITEMS RETURNED: -IMPLANT. ITEMS NOT RETURNED: PUSHER, INTRODUCER, SHRINK LOCK, DISPENSER HOOP, MICROCATHETER, V-GRIP. THE VISUAL ANALYSIS OF THE RETURNED ITEMS FOUND THE IMPLANT TO BE SEPARATED FROM THE PUSHER, STRETCHED AT THE PROXIMAL SECTION, DAMAGED, AND DEFORMED. THE PUSHER WAS NOT RETURNED FOR EVALUATION. INVESTIGATION FOUND THE IMPLANT¿S MONOFILAMENT BROKEN AT THE TIE KNOT WITH A STRETCHED TIP, WHICH INDICATES THE DEVICE EXPERIENCED A TENSILE BREAK. THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE IMPLANT TO BE SEPARATED FROM THE PUSHER, STRETCHED AT THE PROXIMAL SECTION, DAMAGED, AND DEFORMED. THE PUSHER WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION FOUND THAT THE IMPLANT¿S MONOFILAMENT SHOWED A TENSILE BREAK SHAPE AT THE TIP, WHICH IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCE THAT EXCEEDED THE STRENGTH OF THE MONOFILAMENT CAUSING THE IMPLANT TO SEPARATE FROM THE PUSHER. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION. THE MICROCATHETER USED IN THE PROCEDURE WAS NOT RETURNED FOR EVALUATION, SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS STATED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RETURNED. PROCEDURAL OR MEDICAL IMAGING WAS NOT PROVIDED. THE ALLEGED PRODUCT ISSUE OF DETACHMENT AS DESCRIBED COULD NOT BE CONFIRMED. IF THE DEVICE IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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 INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED. PLEASE SEE H6 AND H10.

    Description of Event or Problem · 0

    IT WAS REPORTED ONLY THAT THE COIL SELF-DEPLOYED IN CATHETER WITHOUT USE OF HANDLE. DEVICE WAS NOT DEPLOYED IN THE PATIENT. THE PATIENT IS STABLE AND PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060607 AZUR 18 HYDROCOIL DETACHABLE VASCULAR EMBOLIZATION DEVICE KRD MICROVENTION, INC 45-480204-L 0000273307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown