BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQMAP 3D IMAGING & MAPPING CATHETER

    MDR report key: 10525056 · Received September 11, 2020

    Report

    Report Number
    3012120746-2020-00004
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 11, 2020
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    MTD
    UDI-DI
    00857042007029
    PMA / PMN Number
    K170819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN WHAT CAUSED THE PERICARDIAL EFFUSION. IT IS HIGHLY UNLIKELY THAT THE PERICARDIAL EFFUSION WAS CAUSED BY THE ACQMAP CATHETER. SPECIFICALLY, AS STATED BY THE ACUTUS ACCOUNT MANAGER IN THE EVENT DESCRIPTION, THE ACQMAP CATHETER 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. ALTHOUGH A SINGLE TRANSSEPTAL PUNCTURE WAS USED TO ACCESS THE LEFT ATRIUM, THE PROCEDURE ITSELF IS TECHNICALLY DEMANDING AND CARRIES THE RISK OF SEVERE COMPLICATIONS INCLUDING PERICARDIAL EFFUSION. THE ACUTUS ACCOUNT MANAGER TALKED TO THE PHYSICIAN AFTER THE REPORTED ADVERSE EVENT. THE PHYSICIAN COULD NOT SPECIFICALLY SAY THAT THE ACQMAP CATHETER CAUSED THE EVENT. HOWEVER, SINCE IT CANNOT BE DETERMINED WHAT IF ANY ROLE THE ACUTUS DEVICES MAY HAVE PLAYED IN THIS EVENT, ACUTUS IS REPORTING THIS EVENT TO BE CONSERVATIVE.

    Description of Event or Problem · 1

    PATIENT HISTORY: A MALE PATIENT (AGE (B)(6); WEIGHT (B)(6) KG) WAS TREATED ON (B)(6) 2020. THE DE-NOVO ABLATION WAS USED TO TREAT THE PATIENT'S PAROXSYSMAL ATRIAL FIBRILLATION. THE PATIENT HAD BEEN PRESCRIBED FLECANIDE FOR THE PAROXYSMAL ATRIAL FIBRILLATION. DESCRIPTION OF THE EVENT: IT WAS REPORTED THAT THE BI-ATRIAL PROCEDURAL STEPS BASED ON STANDARD OF CARE WERE UTILIZED TO ACCESS THE PATIENT'S RIGHT AND LEFT ATRIUMS. NOTE: THE BI-ATRIAL USE OF TWO ACQMAP CATHETERS IS ONLY APPROVED IN EUROPE. THE BI-ATRIAL PROCEDURE TYPICALLY REQUIRES TWO TRANSSEPTAL PUNCTURES. HOWEVER, DURING THIS CASE ONLY ONE TRANSSEPTAL PUNCTURE WAS REQUIRED. IT WAS SUSPECTED THAT THE SECOND GUIDEWIRE WAS PLACED IN A FORAMEN OVALE, HOWEVER A TRANSOESOPHAGEAL ECHOCARDIOGRAM AND TRANSTHORACIC ECHOCARDIOGRAM COULD NOT CONFIRM THE GUIDEWIRE PLACEMENT. THE ACQMAP CATHETER AND THE ACQGUIDE STEERABLE SHEATH WERE POSITIONED IN THE RIGHT ATRIUM WHERE A MAP WAS CREATED, AND ABLATIONS WERE PERFORMED WITH THE ABBOTT¿ TACTICATH¿ SENSOR ENABLED CATHETER WITHOUT INCIDENT. THE ACQMAP CATHETER WAS THEN POSITIONED IN THE RIGHT ATRIUM/SUPERIOR VENA CAVA JUNCTION WHILE A SECOND ACQMAP CATHETER WAS PLACED INTO POSITION IN THE LEFT ATRIUM. THE LEFT ATRIUM WAS MAPPED USING THE ACQMAP CATHETER AND ABLATIONS WERE PERFORMED WITH THE ABBOTT¿ TACTICATH¿ SENSOR ENABLED CATHETER WITHOUT INCIDENT. AFTER AN UNKNOWN PERIOD-OF-TIME, THE PHYSICIAN PULLED BACK ON THE RIGHT ATRIAL GUIDEWIRE TO MOVE THE GUIDEWIRE AND ACQMAP CATHETER BACK INTO POSITION TO CREATE ANOTHER RIGHT ATRIAL MAP. DURING THE LAST HOUR OF TREATMENT, THE PATIENT'S BLOOD PRESSURE WAS LOW AND BECAME INCREASINGLY DIFFICULT FOR THE ANESTHESIOLOGIST TO MANAGE. THE LOW BLOOD PRESSURE DID NOT TRIGGER AN ALERT FROM THE ANESTHESIOLOGIST AND THE CASE CONTINUED. UPON COMPLETING THE CASE, A TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED THE PRESENCE OF A PERICARDIAL EFFUSION. A SUBXIPHOID PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 650ML WAS REMOVED FROM THE PERICARDIAL SPACE. THE PERICARDIOCENTESIS DID NOT STABILIZE THE PATIENT. DURING THE PERICARDIOCENTESIS, THE PHYSICIAN NOTED A BLOOD CLOT THAT CAUSED PARTIAL COLLAPSE OF THE PATIENT'S RIGHT VENTRICLE. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE CLOT DURING PERICARDIOCENTESIS. HOWEVER, THE CLOT COULD NOT BE EXTRACTED VIA THE SUBXIPHOID CATHETER DUE TO THE CLOT'S SIZE AND CONSISTENCY. PROTAMINE WAS THEN ADMINISTERED TO REVERSE THE EFFECTS OF HEPARIN ANTICOAGULANT. SURGICAL INTERVENTION WAS NOT NECESSARY TO RESOLVE THE PERICARDIAL EFFUSION OR THE BLOOD CLOT. THE ORIGIN OF THE PERICARDIAL EFFUSION COULD NOT BE DETERMINED. PATIENT STATUS POST EVENT THE PHYSICIAN INFORMED ACUTUS THAT THE PATIENT WAS "DOING WELL" 24 HOURS POST PROCEDURE. NO SUBSEQUENT SEQUELAE HAVE BEEN REPORTED TO ACUTUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989337 ACQMAP 3D IMAGING & MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD ACUTUS MEDICAL, INC. 900003 100383 00857042007029

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R