BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQMAP 3D IMAGING & MAPPING CATHETER

    MDR report key: 11197439 · Received January 19, 2021

    Report

    Report Number
    3012120746-2021-00001
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    December 22, 2020
    Report Date
    February 11, 2021
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    MTD
    PMA / PMN Number
    K170819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4: ADDED LOT NUMBER. D4: ADDED EXPIRATION DATE. D4: ADDED UDI NUMBER. H4: ADDED DEVICE MANUFACTURER DATE.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHAT CAUSED THE PERICARDIAL EFFUSION. IT IS HIGHLY UNLIKELY THAT THE EVENT WAS CAUSED BY THE ACM DEVICES. AS STATED IN THE EVENT DESCRIPTION BY THE ACUTUS ACCOUNT MANAGER, THE ACQMAP CATHETER AND ACQGUIDE MAX SHEATH FUNCTIONED WITHOUT ANY REPORTED INCIDENT THAT WOULD HAVE LED TO THE PERICARDIAL EFFUSION. 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 PERICARDIAL EFFUSION. SINCE IT CANNOT BE DETERMINED WHAT IF ANY ROLE THE ACUTUS DEVICES MAY HAVE PLAYED IN THIS EVENT, ACUTUS IS CONSERVATIVELY REPORTING THIS EVENT.

    Description of Event or Problem · 1

    PATIENT HISTORY: A MALE PATIENT ((B)(6)) WAS TREATED ON (B)(6) 2020. THE REDO ABLATION WAS USED TO TREAT THE PATIENT'S INFREQUENT PREMATURE ATRIAL CONTRACTIONS AND 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 THE ACUTUS MEDICAL INC. (ACM) ACQMAP CATHETER AND ACQGUIDE MAX SHEATH WERE USED DURING THE PROCEDURE AND THAT NO DIFFICULTIES WERE EXPERIENCED IN DEPLOYING, COLLAPSING, AND/OR WITHDRAWING THE ACM DEVICES FOR EACH OF THE 6 MAPS CREATED. THE ABBOTT¿ ENSITE PRECISION¿ CARDIAC MAPPING SYSTEM (PRECISION) AND THE ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ (HD GRID), ALSO WERE USED DURING THE CASE. THE PRECISION AND HD GRID WERE INITIATED TO CREATE AN ANATOMY OF THE LEFT ATRIUM. ALL VEINS HAD BEEN ISOLATED. THE PATIENT WAS INDUCED INTO ATRIAL FIBRILLATION WITH THE ST. JUDE MEDICAL¿ INQUIRY¿ ELECTROPHYSIOLOGY CATHETER, DECAPOLAR. THE ACQMAP CATHETER WAS USED TO CREATE 6 MAPS IN THE LEFT ATRIUM AND SELECTED SITES WERE ABLATED WITH THE ABBOTT¿ TACTICATH¿ SENSOR ENABLED CATHETER. TOWARDS THE END OF THE PROCEDURE AND AFTER ALL THE DEVICES WERE REMOVED THE PATIENT'S BLOOD PRESSURE DROPPED. ROUTINE ULTRASOUND SCAN CONFIRMED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND 600ML OF BLOOD/FLUID WERE REMOVED FROM THE PERICARDIAL SPACE. PROTAMINE WAS THEN ADMINISTERED TO REVERSE THE EFFECTS OF HEPARIN ANTICOAGULANT. SURGICAL INTERVENTION WAS NOT NECESSARY TO RESOLVE THE PERICARDIAL EFFUSION. PATIENT STATUS POST EVENT: THE PHYSICIAN INFORMED ACUTUS THAT THE PATIENT WAS DOING WELL. PATIENT HAS BEEN DISCHARGED AND NO SUBSEQUENT SEQUELAE HAVE BEEN REPORTED TO ACUTUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88731 ACQMAP 3D IMAGING & MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD ACUTUS MEDICAL, INC. 900003 100535

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R ABBOTT¿ ENSITE PRECISION¿ CARDIAC MAPPING SYSTEM| ABBOTT¿ TACTICATH¿ SENSOR ENABLED CATHETER| ACQGUIDE MAX SHEATH| ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿| ST. JUDE MEDICAL¿ INQUIRY¿