BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE

    MDR report key: 20043654 · Received August 22, 2024

    Report

    Report Number
    3012120746-2024-00017
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 25, 2024
    Report Date
    October 10, 2024
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DRE
    UDI-DI
    00850027837154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, BUT IS EXPECTED. INVESTIGATION FINDINGS AND CONCLUSIONS PENDING THE COMPLETION OF DEVICE ANALYSIS. DEVICE IS NOT DISTRIBUTED IN THE US.

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE DAMAGE OR DEFECT FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. PERICARDIAL EFFUSION IS A POTENTIAL CLINICAL RISK ASSOCIATED WITH THE ACQCROSS DEVICE, WHICH IS THE SAME AS THE RISK OF A PROCEDURE PERFORMED WITH SIMILAR, COMPETITIVE DEVICES. NO NON-CONFORMANCES WERE FOUND AFTER ANALYSIS OF PRODUCTION RECORDS. CORRECTION: H6

    Description of Event or Problem · 0

    DURING A CRYO ABLATION PROCEDURE THE INITIAL ACQCROSS DEVICE WAS REPLACED DUE TO DIFFICULTIES REMOVING THE GUIDEWIRE. PRIOR TO THE TRANSSEPTAL PUNCTURE WITH THE REPLACEMENT DEVICE, THE PHYSICIAN SHOT CONTRAST AND OBSERVED A SLIGHTLY STRANGE ANGLE OF THE NEEDLE HOWEVER THE SEPTUM WAS STAINING BEAUTIFULLY. HE NOTED THAT THE NEEDLE/SHEATH WAS IN QUITE AN UPRIGHT POSITION WITH NOT MUCH CURVE. THE PHYSICIAN COMPLETED THE TRANSSEPTAL PUNCTURE AND INJECTED CONTRAST TO CONFIRM HIS PLACEMENT IN THE LA. THE CONTRAST SEAMED TO HEAD SUPERIORLY AND TO HIGHLIGHT THE VESSELS THAT COME OFF OF THE AORTA. AT THIS POINT, THE PHYSICIAN WAS SUSPECTING THAT THE AORTA HAD BEEN PUNCTURED. HE CALLED FOR PROTAMINE TO BE ADMINISTERED TO THE PATIENT AND CALLED FOR A CARDIAC ECHO. THE PATIENTS BLOOD PRESSURE WAS NORMAL. THE FLURO IMAGES WERE REVIEWED BY TWO PHYSICIANS. THE ECHO WAS THEN PERFORMED AND A SMALL PERICARDIAL EFFUSION WAS NOTED, SO SMALL THAT IT COULD HAVE BEEN PRESENT PRIOR TO THE PROCEDURE, IT WAS NOT CLEAR. THE PHYSICIAN ABORTED THE PROCEDURE AND WAITED 15 MIN TO REDO THE ECHO OF THE PATIENT'S HEART. THE EFFUSION PERSISTED BUT HAD NOT CHANGED IN SIZE. THE PATIENT REMAINED STABLE WITH NO CHANGES TO BLOOD PRESSURE. THE PATIENT WAS ADMITTED OVERNIGHT AND WAS RESCHEDULED FOR THE PROCEDURE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581578 ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE INTEGRATED TRANSSEPTAL DILATOR/NEEDLE DRE ACUTUS MEDICAL, INC. 900304 105367 00850027837154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L| H