BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 22538945 · Received July 17, 2025

    Report

    Report Number
    2032493-2025-90336
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 23, 2025
    Report Date
    August 30, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORT DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE US. THIS COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (SIMILAR TO V-TRAK HYDROSOFT 3D, 510(K)# K161367). THE DEVICE WAS STATED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, IT HAS NOT YET BEEN RETURNED. SOME IMAGES OF THE DEVICE WERE PROVIDED FOR INVESTIGATION AND REVIEW OF THEM IS CURRENTLY ONGOING. THE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 0

    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 FOUND ON THE PUSHER HEATER COIL. FURTHER INSPECTION FOUND THE PUSHER TO BE DAMAGED AND STRETCHED AT THE DISTAL 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 BUILD RECORD FOR LOT 0000918946 INDICATES THAT THE IMPLANT WAS PRESENT WITHIN THE FINAL PACKAGING AND ATTACHED TO THE PUSHER PRIOR TO RELEASE. FURTHERMORE, AS THE POUCH WAS RETURNED OPEN, THIS INVESTIGATION COULD NOT EXAMINE THE DEVICE IN ITS OUT-OF-BOX CONDITION TO FURTHER ASSESS THE ALLEGED PRODUCT ISSUE AND THEREFORE, THIS COMPLAINT IS CONSIDERED NON-VERIFIABLE. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE STRETCHED AND DAMAGED PUSHER, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES EXCEEDING THE PUSHER'S YIELD STRENGTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM ITS HOLDER, THE IMPLANT WAS MISSING AND NOT ATTACHED TO THE DELIVERY PUSHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM ITS HOLDER, THE IMPLANT WAS MISSING AND NOT ATTACHED TO THE DELIVERY PUSHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565902 AZUR SOFT3D DETACHABLE 10 DEVICE VASCULAR FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS00310 0000918946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown