BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR HYDROPACK 18

    MDR report key: 19226951 · Received May 1, 2024

    Report

    Report Number
    2032493-2024-00348
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 9, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MICROVENTION, INC
    Product Code
    KRD
    UDI-DI
    00842429118085
    PMA / PMN Number
    K223050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS STATED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RETURNED. THE ALLEGED PRODUCT ISSUE OF PREMATURE SEPARATION AND THE INCIDENT 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 THE REPORTED 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. H3 OTHER TEXT : NOT RETURNED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS. ITEMS RETURNED FOR EVALUATION: IMPLANT. ITEMS NOT RETURNED FOR EVALUATION: PUSHER. INTRODUCER. SHRINK LOCK. DISPENSER HOOP. MICROCATHETER. GRIP. THE VISUAL ANALYSIS OF THE RETURNED ITEMS FOUND THE IMPLANT STRETCHED AT THE PROXIMAL SECTION WITH THE GEL AND MONOFILAMENT EXPOSED AND SEPARATED FROM THE PUSHER. THE PUSHER WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION OF THE IMPLANT FOUND THE MONOFILAMENT BROKEN, WHICH INDICATES THE DEVICE EXPERIENCED A TENSILE BREAK. INVESTIGATION CONCLUSION. THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE IMPLANT STRETCHED AT THE PROXIMAL SECTION WITH THE GEL AND MONOFILAMENT EXPOSED AND SEPARATED FROM THE PUSHER. THE PUSHER WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION FOUND THE IMPLANT'S MONOFILAMENT WITH A TENSILE BREAK SHAPE AT THE TIP, WHICH IS CONSISTENT WITH THE DEVICE EXPERIENCING EXCESSIVE FORCE THAT EXCEEDED THE STRENGTH OF THE MONOFILAMENT CAUSING THE IMPLANT TO SEPARATE FROM THE PUSHER. 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. 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. 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

    AS REPORTED: THE PHYSICIAN WAS TRYING TO BRING BACK THE HYDROPACK AND THE FILAMENT APPEARS TO HAVE SNAPPED DETACHING THE COIL BEFORE IT WAS INTENDED TO DETACH. NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ALTHOUGH ADDITIONAL PATIENT AND INCIDENT INFORMATION WAS REQUESTED, THE REPORTER STATED THEY WERE UNABLE TO PROVIDE REQUESTED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409888 AZUR HYDROPACK 18 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC 45-880060 0000444817 00842429118085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown