BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 21903514 · Received April 24, 2025

    Report

    Report Number
    2032493-2025-90105
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 3, 2025
    Manufacturer
    MICROVENTION INC.
    Product Code
    KRD
    UDI-DI
    04987892128431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE PUSHER HYPOTUBE KINKED AT THE DISTAL SECTION, AND THE IMPLANT DAMAGED, DEFORMED, AND SEPARATED FROM THE PUSHER WITH THE MONOFILAMENT EXPOSED. THE UNIT DID NOT PASS CONTINUITY AND RESISTANCE TESTING. THE EXPOSED 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. FURTHER INVESTIGATION FOUND THE YELLOW LEAD WIRE BROKEN AT THE DISTAL SOLDER JOINT, WHICH IS CONSISTENT WITH NON-DETACHMENT. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE PUSHER AND IMPLANT DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES EXCEEDING THE PUSHER AND IMPLANT'S YIELD STRENGTH. 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 PRODUCT REPORTED IN THIS REPORT IS AN EXPORTED DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE U. S. THE 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 BUT HAS NOT YET BEEN RETURNED. THE ALLEGED PRODUCT ISSUE/EVENT 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

    SEE H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A COMPETITOR MICROCATHETER WAS NAVIGATED TO THE THIRD ILIAC ARTERY VIA A CATHETER. BY A RETROGRADE APPROACH AND ENGAGED WITH THE LEAK. NBCA WAS INJECTED INTO THE ANEURYSM SAC AND THE COIL CONCERNED WAS ATTEMPTED TO BE PLACED TO SEAL THE NBCA. THE COIL WAS INSERTED INTO THE PATIENT WITHOUT PRETESTING. AS THE COIL WAS POSITIONED AT THE TARGET SITE, DETACHMENT WAS ATTEMPTED. HOWEVER, THE V-GRIP FAILED TO DETACH THE COIL AS THE RED LIGHT APPEARED. SUSPECTING A MALFUNCTION OF THE V-GRIP, THE V-GRIP WAS REPLACED WITH ANOTHER V-GRIP. HOWEVER, THE REPLACEMENT V-GRIP ALSO FAILED TO DETACH THE COIL AS THE LIGHT INDICATED RED. THE COIL WAS THEREFORE DETERMINED TO BE DEFECTIVE, AND AN ATTEMPT WAS MADE TO REMOVE THE COIL FROM THE PATIENT, BUT THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE COIL WAS THEN SUCCESSFULLY REMOVED FROM THE PATIENT ALONG WITH THE MICROCATHETER. ANOTHER AZUR COIL OF THE SAME SIZE THAT PASSED THE PRETEST WAS DELIVERED AND SUCCESSFULLY PLACED AT THE TARGET SITE. ANOTHER LEAK WAS OBSERVED FROM THE FOURTH ILIAC ARTERY, BUT THE LOCATION OF THE LEAK WAS DETERMINED TO BE DIFFICULT TO APPROACH. THEREFORE, THE PROCEDURE WAS ENDED WITHOUT FURTHER TREATMENT. THE PATIENT CONDITION WAS REPORTED AS NO HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226955 AZUR SOFT3D DETACHABLE 10 DEVICE VASCULAR FOR PROMOTING EMBOLIZATION KRD MICROVENTION INC. MV-HS00520 0000503103 04987892128431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown