BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 17283255 · Received July 7, 2023

    Report

    Report Number
    2032493-2023-00831
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 16, 2023
    Report Date
    August 15, 2023
    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

    AT THE TIME THIS COMPLAINT WAS RECEIVED, THIS PRODUCT WAS AN EXPORTED DEVICE THAT WAS 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 RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, 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.

    Additional Manufacturer Narrative · 0

    H10: ITEMS RETURNED FOR EVALUATION: PUSHER. ITEMS NOT RETURNED FOR EVALUATION: IMPLANT; INTRODUCER; DISPENSER HOOP; SHRINK LOCK; MICROCATHETER; V-GRIP. THE VISUAL ANALYSIS OF THE RETURNED ITEMS FOUND THAT THE PUSHER WAS RETURNED WITHOUT THE IMPLANT ATTACHED, AND THE PUSHER HEATER COIL WAS BURNT. FURTHER INSPECTION FOUND THAT ONLY ONE PUSHER WAS RETURNED WITH THE DISTAL SECTION STRETCHED AND WRINKLED, AND THE PROXIMAL SECTION SEVERELY STRETCHED, TANGLED, AND BROKEN. THE PROXIMAL PORTION OF THE PUSHER WAS NOT RETURNED FOR EVALUATION. UPON CONDUCTING A THOROUGH INSPECTION, NO IMPLANTS WERE FOUND TANGLED WITH THE PUSHER. THE INVESTIGATION FOUND THAT THE PUSHER WAS RETURNED WITH NO IMPLANT ATTACHED AND THE PUSHER HEATER COIL SHOWED SIGNS OF ACTIVATION USING A DETACHMENT CONTROLLER. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. FURTHER INVESTIGATION FOUND THAT THE DISTAL SECTION OF THE PUSHER WAS STRETCHED AND WRINKLED, WHILE THE PROXIMAL SECTION EXHIBITED SEVERE STRETCHING, TANGLING, AND BREAKAGE. THE PROXIMAL PORTION OF THE PUSHER WAS ALSO NOT RETURNED FOR EVALUATION. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED: ISSUE OCCURRED DURING A LUMBAR ARTERY EMBOLIZATION PRIOR TO EVAR FOR PREVENTION OF ENDOLEAKS. THE LENGTH OF SECOND COIL USED FOR EMBOLIZATION OF THE FOURTH LUMBAR ARTERY WAS DETERMINED TO BE INSUFFICIENT. DURING WITHDRAWAL, THE COIL ENCOUNTERED RESISTANCE. THE COIL WAS REMOVED FROM THE PATIENT AND FOUND TO BE STRETCHED. IT APPEARED THAT TWO COILS WERE ENTANGLED, SO THE POSSIBILITY CANNOT BE RULED OUT THAT THE FIRST COIL CAUGHT ON THE SECOND COIL AND WAS WITHDRAWN ALONG WITH THE SECOND COIL. IT WAS CONFIRMED VIA FLUOROSCOPY THAT THE 1ST COIL WAS NOT IN PLACE AFTER THEY REMOVED THE 2ND COIL. THE PHYSICIAN DETERMINED THERE WERE NO COMPLICATIONS NOTED IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783287 AZUR SOFT3D DETACHABLE 10 VASCULAR EMBOLIZATION DEVICE KRD MICROVENTION, INC MV-HS00520 0000312641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BREAKTHROUGH.