BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED NEEDLE/DILATOR

    MDR report key: 19802059 · Received July 22, 2024

    Report

    Report Number
    3012120746-2024-00015
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    April 11, 2024
    Report Date
    July 22, 2024
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND IS UNAVAILABLE FOR INVESTIGATION. DEVICE IDENTIFICATION INFORMATION WAS NOT PROVIDED. A ROOT CAUSE COULD NOT BE ESTABLISHED IN THIS CASE.

    Description of Event or Problem · 0

    DURING THE INSERTION OF A VASCULAR SHEATH WITH A NEEDLE (FLEXCATH AND ACQCROSS) INTO THE ATRIAL SEPTUM, THE GUIDEWIRE WAS BLOCKED IN THE SHEATH, PREVENTING THE PUNCTURE. THE CHAIN WAS REMOVED FROM THE JACKET USING FORCE AND REPLACED WITH ANOTHER HYDROPHILIC ONE. CONTINUATION OF THE PROCEDURE WITHOUT COMPLICATIONS. PER FOLLOW-UP WITH THE REP THE ACUTUS PROVIDED GUIDEWIRE WAS USED IN THIS CASE. RESISTANCE WAS NOTED AS THE GUIDEWIRE WAS LOADED INTO THE SHEATH. IT WAS BELIEVED THAT THE GUIDEWIRE LUMEN WAS TOO LARGE FOR THE SHEATH. IT WAS UNCLEAR WHAT CAUSED THE FAILURE OR WHETHER THE GUIDEWIRE HAD MALFUNCTIONED. ADDITIONAL INFORMATION WAS RECEIVED FROM USER (PHYSICIAN) STATING THAT, PER TRANSLATION, "DURING CONSULTATION, A SIGNIFICANT INCREASE IN BLOOD PRESSURE WAS OBSERVED FOLLOWING THE ADMINISTRATION OF THE DRUG. THE PATIENT REPORTED SEVERE HEADACHES AND DIZZINESS. PATIENT RECEIVED THE MEDICATION TO MANAGE A HYPERTENSIVE CRISIS AND EXPERIENCED ADVERSE REACTIONS INCLUDING SIGNIFICANT INCREASE IN BLOOD PRESSURE. THE PATIENT MADE A FULL RECOVERY WITH NO LASTING EFFECTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440010 INTEGRATED NEEDLE/DILATOR DRE ACUTUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention