BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HP8 AZUR HYDROPACK 18

    MDR report key: 23719554 · Received December 4, 2025

    Report

    Report Number
    2032493-2025-90687
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 4, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00842429118085
    PMA / PMN Number
    K223050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE OR DIFFICULT COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, THE PHYSICIAN WAS PERFORMING AN ENDOLEAK EMBO. A 2.8 X150CM PROGREAT IN PLACE. AN ATTEMPT TO DELIVER A 60CM HYDROPACK. IT WASN'T FORMING AS DESIRED AND WANTED TO PULLED BACK LIGHTLY TO REPOSITION. FELT IT POP WHEN THE DEVICE WAS PULLED BACK AND REALIZED THE COIL HAD DETACHED. THE PHYSICIAN ENDED UP HAVING TO PULL OUT THE WHOLE SYSTEM AND NOW HAS TO BRING THE PATIENT BACK ANOTHER DAY TO REPEAT PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130693 HP8 AZUR HYDROPACK 18 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. 45-880060 0001066695 00842429118085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R