BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

    MDR report key: 24901369 · Received April 16, 2026

    Report

    Report Number
    2124215-2026-20765
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    March 26, 2026
    Report Date
    May 11, 2026
    Manufacturer
    BAYLIS MEDICALE CIE INC
    Product Code
    DXF
    PMA / PMN Number
    K150709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION (RETAINED BY FACILITY). IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. GOOD FAITH EFFORT ATTEMPTS TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT ARE IN PROGRESS, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A CONCOMITANT PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND ATRIAL FIBRILLATION ABLATION PROCEDURE, A FARAWAVE CATHETER AND VERSACROSS CONNECT FOR FARADRIVE WERE SELECTED FOR USE. THE PVC TREATMENT WAS PLANNED AND THE PHYSICIAN FIRST GAINED ACCESS TO THE LEFT VENTRICLE IN RETROGRADE FASHION. THE LEFT VENTRICLE WAS MAPPED WITH A A NON-BOSTON SCIENTIFIC RADIO FREQUENCY (RF) CATHETER IN WHICH A POTENTIAL ABLATION TARGET WAS FOUND. PHYSICIAN ABLATED IN THE LEFT VENTRICLE AND APPEARED TO TERMINATE PVC ORIGIN SITE. FOLLOWING THIS FIRST ABLATION, A PVC WITH A SLIGHTLY DIFFERENT MORPHOLOGY PRESENTED ITSELF THROUGH DATA COLLECTED INTRAOPERATIVELY. THE PHYSICIAN MAPPED THE CORONARY SINUS WITH SAME RF CATHETER. THE POTENTIAL ORIGIN OF THE PVC WAS HYPOTHESIZED TO BE IN THE CORONARY SINUS. THE PHYSICIAN ABLATED WITHIN THE CORONARY SINUS. THE TEAM AND MAPPER NOTED MOMENTS OF POTENTIAL CONCERN DURING ABLATION OF THE CORONARY SINUS. THERE WERE NO BOSTON SCIENTIFIC'S PRODUCTS WERE USED IN THE PATIENT DURING THIS PORTION OF THE PROCEDURE. THE PHYSICIAN CONCLUDED THE PVC PORTION OF PROCEDURE. THE PHYSICIAN BEGAN TO TREAT PATIENT'S ATRIAL FIBRILLATION. THE TRANSSEPTAL ACCESS WAS ACHIEVED VERSACROSS CONNECT AND FARADRIVE SHEATH. TRANSSEPTAL ACCESS DID NOT OUTWARDLY PRESENT ANY OBSTACLES OR AREAS OF CONCERN. THE VERSACROSS WIRE WAS TRACKED VIA FLUOROSCOPY, INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND A NON-BOSTON SCIENTIFIC MAPPING SYSTEM. AFTER GAINING ACCESS INTO THE LEFT ATRIUM, FARAWAVE 2.0 CATHETER WAS INSERTED INTO THE BODY. THE PHYSICIAN DELIVERED TWO LESIONS IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) USING THE FARAWAVE'S BASKET CONFIGURATION WHEN A PERICARDIAL EFFUSION WAS NOTED. TOTAL ABLATION INCLUDING THOSE FROM NON-BOSTON SCIENTIFIC SYSTEM HAD TAKEN PLACE FOR APPROXIMATELY 35-40 MINUTES. THE PHYSICIAN ABORTED ABLATION PROCEDURE AND CHOSE TO PERFORM A PERICARDIOCENTESIS TO TREAT THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT STAYED IN THE LAB AND WAS NOT TRANSPORTED DURING THE PROCEDURE. THE PATIENT BECAME STABLE AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (RETAINED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462521 VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICALE CIE INC

    Patients

    Seq Age Sex Outcome Treatment
    1