BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 21689190 · Received March 25, 2025

    Report

    Report Number
    2032493-2025-00256
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 25, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128561
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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). THIS IS REPORT 1 OF 2. THE DEVICE ASSOCIATED WITH THIS EVENT WAS USED DURING THE SAME PROCEDURE REFERENCED IN MFR. REPORT#: 2032493-2025-00255. INVESTIGATION CONCLUSION: THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE PROXIMAL CONNECTOR KINKED AND THE IMPLANT STRETCHED AT THE PROXIMAL SECTION, WHICH IS CONSISTENT WITH THE ALLEGED PRODUCT ISSUE. THE STRETCHED CONDITION IS CONSISTENT WITH THE COIL BECOMING STUCK OR EXPERIENCING FRICTION DURING REPOSITIONING WITHIN THE TARGET SITE (I.E., STUCK ON PREVIOUSLY IMPLANTED COILS OR THE TIP OF THE MICROCATHETER). 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, 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 THE COIL IMPLANTS WERE USED TO EMBOLIZE A UTERINE ARTERY ANEURYSM. THE FIRST COIL WAS DETACHED AND IMPLANTED IN THE PATIENT AFTER MULTIPLE ATTEMPTS USING 3 DETACHMENT CONTROLLERS. THE CONCERNED SECOND COIL ATTEMPTED EXPERIENCED RESISTANCE, STOPPED ADVANCING AND GOT STUCK IN THE MICROCATHETER. ANOTHER ATTEMPT WAS MADE AFTER THE MICROCATHETER WAS FLUSHED, BUT THE COIL GOT STUCK IN THE MICROCATHETER AND DID NOT ADVANCE ANY FURTHER. THE COIL WAS THEREFORE WITHDRAWN USING A SNARE AND REMOVED FROM THE PATIENT (REFERENCE MFR. REPORT#: 2032493-2025-00255). THE COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME MODEL, WHICH WAS IMPLANTED WITHOUT PROBLEMS. ANOTHER COIL (SUBJECT OF THIS REPORT) WAS THEN INSERTED INTO THE MICROCATHETER WITHOUT PROBLEMS, BUT ANGIOGRAPHY CONFIRMED THAT THE IMPLANT WAS NOT POSITIONED WELL AND THE PHYSICIAN FELT SNAPPING DURING COIL ADVANCEMENT. AS THE PHYSICIAN WAS NOT SURE IF THE IMPLANT WAS DETACHED OR STRETCHED AT THAT TIME, THE COIL WAS ONCE WITHDRAWN USING A SNARE AND REMOVED FROM THE PATIENT. THE IMPLANT WAS FOUND TO BE STRETCHED. THE COIL WAS THEN REPLACED WITH ANOTHER COIL TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804472 AZUR SOFT3D DETACHABLE 10 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS01036 0000586201 04987892128561

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 1.9 F PIOLAX CATHETER (BISHOP).| 4 FR RADIFOCUS INTRODUCER SHEATH.| 4 FR SHEPHERD HOOK CATHETER.| AZUR CX 18D-LONGE STENT (MICROVENTION).| AZUR DETACHMENT CONTROLLER (X3) (MICORVENTION).| SYNCHRO 2 GUIDEWIRE (STRYKER).