BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQCROSS QX

    MDR report key: 15470556 · Received September 23, 2022

    Report

    Report Number
    3012120746-2022-00003
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    August 17, 2022
    Report Date
    September 22, 2022
    Manufacturer
    ACUTUS MEDICAL, INC
    Product Code
    DYB
    UDI-DI
    00850027837161
    PMA / PMN Number
    K210685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACUTUS MEDICAL, INC. INDICATED PATIENT AGE AS 50 SINCE ACUTUS MEDICAL WAS NOT PROVIDED WITH THAT INFORMATION. PRODUCT WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE A CARDIAC TAMPONADE OCCURRED IN THE PATIENT'S LEFT ATRIUM WHILE UTILIZING THE ACQGUIDE MAX 2.0 SHEATH AND ACQCROSS MAX TRANSSEPTAL. THE TAMPONADE WAS SLOW LEAKING. REPORTEDLY, THE PHYSICIAN SUSPECTED THE CAUSE OF THE EVENT WAS THE .032 GUIDEWIRE. AN ACUTUS REPRESENTATIVE MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE HOWEVER FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567364 ACQCROSS QX ACQCROSS QX - MAX 70CM (US) DYB ACUTUS MEDICAL, INC 900305-001 00850027837161

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Life Threatening| R ACQGUIDE MAX 2.0 SHEATH| GUIDEWIRE: .32" GUIDEWIRE