BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQMAP HIGH RESOLUTION IMAGING + MAPPING SYSTEM

    MDR report key: 10623443 · Received October 2, 2020

    Report

    Report Number
    3012120746-2020-00005
    Event Type
    Injury
    Date Received
    October 2, 2020
    Date of Event
    September 7, 2020
    Report Date
    October 2, 2020
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    00857042007296
    PMA / PMN Number
    K190131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 TAMPONADE. THE POTENTIAL MISALIGNMENT OF THE ABLATION CATHETER WITHIN THE ANATOMICAL MAP WAS INVESTIGATED BY ACUTUS. RESULTS OF THE INVESTIGATION COULD NOT DETERMINE WHAT IF ANY ROLE THE ACUTUS DEVICES MAY HAVE PLAYED IN THIS EVENT. ACUTUS IS REPORTING THIS EVENT TO BE CONSERVATIVE. PLEASE NOTE: ACUTUS MEDICAL, INC. INDICATED PATIENT WEIGHT AS 0 SINCE THE INFORMATION PROVIDED TO ACUTUS MEDICAL, INC. WAS RECORDED AS 22 BMI.

    Description of Event or Problem · 1

    PATIENT HISTORY: A MALE PATIENT (AGE (B)(6); WEIGHT 22 BMI) WAS TREATED ON (B)(6) 2020. THE DE-NOVO ABLATION WAS USED TO TREAT THE PATIENT'S PAROXSYSMAL ATRIAL FIBRILLATION. IT IS UNKNOWN IF THE PATIENT WAS ON ANY MEDICATION PRIOR TO THE PROCEDURE. DESCRIPTION OF THE EVENT: AN ACUTUS REPRESENTATIVE ATTENDED THE PROCEDURE. IT WAS REPORTED THAT NORMAL PROCEDURAL STEPS BASED ON STANDARD OF CARE WERE UTILIZED TO ACCESS THE PATIENT'S LEFT ATRIUM. A TOTAL OF 5 MAPS WERE CREATED WITH THE ACQMAP CATHETER WITHOUT INCIDENT. A 6TH MAP WAS CREATED TO INFORM PULMONARY VEIN ISOLATION (PVI) STRATEGY. THE ABBOTT¿ TACTICATH¿ SENSOR ENABLED CATHETER WAS INTRODUCED INTO THE LEFT ATRIUM. PRIOR TO ABLATING, THE PHYSICIAN STATED THAT THE POSITION OF THE ABLATION CATHETER DID NOT APPEAR TO BE ALIGNED WITH THE ANATOMICAL MAP BUT CONTINUED TO PERFORM THE PVI ABLATION. AT THIS POINT THE PATIENT'S BLOOD PRESSURE DROPPED. A TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED THAT A TAMPONADE OCCURRED. A SUBXIPHOID PERICARDIOCENTESIS WAS PERFORMED AND AN UNKNOWN AMOUNT OF BLOOD/FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PERICARDIOCENTESIS STABILIZED THE PATIENT. PROTAMINE WAS THEN ADMINISTERED TO REVERSE THE EFFECTS OF HEPARIN ANTICOAGULANT. SURGICAL INTERVENTION WAS NOT NECESSARY TO RESOLVE THE TAMPONADE. THE ORIGIN OF THE TAMPONADE COULD NOT BE DETERMINED. THE CASE WAS ABORTED. PATIENT STATUS POST EVENT THE PHYSICIAN INFORMED ACUTUS THAT THE PATIENT WAS "STABLE" 48 HOURS POST PROCEDURE. NO SUBSEQUENT SEQUELAE HAVE BEEN REPORTED TO ACUTUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087374 ACQMAP HIGH RESOLUTION IMAGING + MAPPING SYSTEM PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ACUTUS MEDICAL, INC. 800500 00857042007296

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R