BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR

    MDR report key: 24847338 · Received April 11, 2026

    Report

    Report Number
    2032493-2026-00239
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 20, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00842429118054
    PMA / PMN Number
    K223050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE IMPLANT COIL SEPARATED FROM THE PUSHER, STRETCHED, BROKEN, AND ENTANGLED, WHICH IS CONSISTENT WITH THE ALLEGED PRODUCT ISSUE. THE PUSHER WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION FOUND THE IMPLANT'S MONOFILAMENT AT THE TIE KNOT 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 STRETCHED AND BROKEN IMPLANT, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES EXCEEDING THE IMPLANT'S YIELD AND TENSILE STRENGTH.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 2.4 PROGREAT MICROCATHETER. 6 FR ANSEL SHEATH. MUSTANG BALLOON. CX, RUBY LP, EMBOLD AND NESTER COILS. V-GRIP: 45-4001, LOT# 0001168175. 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 ANALYSIS AND THE INVESTIGATION ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PLEASE SEE SECTION H11 FOR DEVICE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SPLENIC ANEURYSM EMBOLIZATION CASE, THERE WAS EXTREME TORTUOSITY, THE DOCTOR WAS USING A MICROCATHETER WITH AN 0.18 GT-R, THE MICROCATHETER TRACKED THROUGH THE TORTUOSITY EASILY. THE PROVIDER WAS ABLE TO DEPLOY MULTIPLE COILS THROUGH THE MICROCATHETER. HE TRIED TO DEPLOY A NON-MICROVENTION PACKING COIL AND TRIED TO MANIPULATE THE MICROCATHETER WHILE THE COIL WAS IN THE CATHETER AND ENCOUNTERED AN ISSUE WHERE THE NON-MICROVENTION COIL DETACHED PREMATURELY. THE PROVIDER WAS ABLE TO PUSH THAT COIL OUT, HE FLUSHED THE MICROCATHETER AND PERFORMED AN ANGIOGRAM. HE THEN TRIED TO ADVANCE A 20CM HYRDOPACK COIL AND ENCOUNTERED RESISTANCE. HE TRIED TO REMOVE THE HYDROPACK AND THE COIL GOT STUCK AND BROKE. HE REMOVED THE PUSHER WIRE AND THE PORTION THAT HAD BROKEN, THE COIL STARTED TO UNRAVEL BUT HE REMOVED THE MICROCATHETER WHICH HAD THE REMAINDER OF THE BROKEN COIL WITHIN IT WITH NO ISSUES. THE CASE FINISHED WITH NO OTHER ISSUES AND THE PATIENT WAS ABLE TO GO TO RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333703 AZUR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. 45-880020 0001204021 00842429118054

    Patients

    Seq Age Sex Outcome Treatment
    1