BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQCROSSTM QX INTEGRATED TRANSSEPTALDILATOR/NEEDLE

    MDR report key: 14048141 · Received April 7, 2022

    Report

    Report Number
    3012120746-2022-00001
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    February 21, 2022
    Report Date
    April 7, 2022
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DRE
    UDI-DI
    00850027837161
    PMA / PMN Number
    K210685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION. UPON RECEIPT OF THE FOLLOWING INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED. CURRENT PATIENT STATUS. AGE AND DOB: BEST ESTIMATE FOR REQUIRED FIELD WAS USED. PATIENT SEX: BEST ESTIMATE FOR REQUIRED FIELD WAS USED. PATIENT WEIGHT: BEST ESTIMATE FOR REQUIRED FIELD WAS USED. THERE WERE SEVERAL PROCEDURE-RELATED OPPORTUNITIES THAT MAY HAVE CONTRIBUTED TO OR CAUSED THE EVENT. THE PROCEDURE ITSELF IS TECHNICALLY DEMANDING AND CARRIES THE RISK OF SEVERE COMPLICATIONS INCLUDING PERFORATION. SINCE IT CANNOT BE DETERMINED WHAT IF ANY ROLE THE ACUTUS DEVICES MAY HAVE PLAYED IN THIS EVENT, ACUTUS IS CONSERVATIVELY REPORTING THIS EVENT. PROBLEMS WITH MY WEBTRADER ACCOUNT RESULTED IN A LATE FILING OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT USING THE ACQGUIDE MAX (LN101953) AND ACQCROSS MAX (LN102010) TO GO TRANSEPTAL, THE DEVICE MOVED OFF THE SEPTUM AND PUNCTURED THE RIGHT ATRIAL WALL. SURGICAL REPAIR WAS COMPLETED ON THE PATIENT. THERE IS NO REPORT OR ALLEGATION OF AN ACUTUS PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329190 ACQCROSSTM QX INTEGRATED TRANSSEPTALDILATOR/NEEDLE TRANSSEPTAL DILATOR/NEEDLE DRE ACUTUS MEDICAL, INC. 900305 102010 00850027837161

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Prefer Not To Disclose Life Threatening| R ACQGUIDE MAX SHEATH (LN101953)