BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROFILL HELICAL

    MDR report key: 20207961 · Received September 12, 2024

    Report

    Report Number
    2032493-2024-00679
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MICROVENTION INC.
    Product Code
    KRD
    UDI-DI
    00816777024411
    PMA / PMN Number
    K113457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ANALYSIS IS CURRENTLY ONGOING.

    Additional Manufacturer Narrative · 0

    ITEMS RETURNED FOR EVALUATION: -PUSHER -INTRODUCER -DISPENSER HOOP ITEMS NOT RETURNED FOR EVALUATION: -IMPLANT -SHRINK LOCK -MICROCATHETER THE VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE IMPLANT WAS NOT ATTACHED TO THE PUSHER, AND THE PUSHER HYPOTUBE KINKED AT THE MIDDLE SECTION. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE INTRODUCER WAS RETURNED UNDAMAGED. THE INTRODUCER DISTAL TIP WAS FOUND TO BE WITHIN SPECIFICATION (SPEC= 0.0180" -0.0005/+0.001). THE INVESTIGATION FOUND THE PUSHER'S MONOFILAMENT BROKEN, WHICH INDICATES THAT THE DEVICE EXPERIENCED A TENSILE BREAK. THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE PUSHER RETURNED WITHOUT THE IMPLANT ATTACHED, BUT NO INDICATIONS OF ACTIVATION USING A DETACHMENT CONTROLLER WAS OBSERVED ON THE PUSHER HEATER COIL. FURTHER INSPECTION FOUND THE PUSHER HYPOTUBE TO BE KINKED AT THE MIDDLE SECTION. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION FOUND THE PUSHER¿S MONOFILAMENT WITH 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 PUSHER DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION. THE MICROCATHETER USED IN THE PROCEDURE WAS NOT RETURNED, SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE IN THE MICROCATHETER AND THEN DETACHED UNEXPECTEDLY. THERE WAS NO INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE "FINE AND WELL." ANOTHER EMBOLIZATION COIL IMPLANT ENCOUNTERED THE SAME ISSUE DURING THE CASE AND WAS REPORTED UNDER A SEPARATE MEDICAL DEVICE REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE IN THE MICROCATHETER AND THEN DETACHED UNEXPECTEDLY. THERE WAS NO INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE "FINE AND WELL." ANOTHER EMBOLIZATION COIL IMPLANT ENCOUNTERED THE SAME ISSUE DURING THE CASE AND WAS REPORTED UNDER SEPARATE MEDICAL DEVICE REPORT 2032493-2024-00683.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622079 HYDROFILL HELICAL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION INC. 100620HFIL-V-A2 0000584157 00816777024411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown