BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS ACCESS SOLUTION

    MDR report key: 16770569 · Received April 19, 2023

    Report

    Report Number
    2124215-2023-15895
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    March 21, 2023
    Report Date
    September 5, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K150709
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDA DIFFERENT MANUFACTURER NOTIFICATION PER (B)(4). IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION WAS MADE TO B1. ADDITIONAL INFORMATION WAS ADDED TO B5. REPORT BEING SUBMITTED ON UNKNOWN VERSACROSS ACCESS SOLUTION KIT (RF WIRE, SHEATH, AND DILATOR) PRO CODE (PRODUCT CODE): DYB, DXF. PREMARKET / 510(K) # K150709, K190688. FDA DIFFERENT MANUFACTURER NOTIFICATION PER-2023-0047457. PERICARDIAL EFFUSION IS A KNOWN INHERENT RISK ASSOCIATED WITH ALL CARDIAC ABLATION PROCEDURES AND IS OUTLINED IN PRODUCT LABELING. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED OBSERVATION OF EFFUSION IN THIS CASE WAS NOT DUE TO A PRODUCT PERFORMANCE-RELATED CAUSE. SINCE THE DEVICE WAS NOT RETURNED TI BOSTON SCIENTIFIC FOR ANALYSIS, BOSTON SCIENTIFIC CONCLUDES THE REPORTED OBSERVATION OF DIFFICULTY CROSSING WAS NOT CONFIRMED THROUGH INVESTIGATIONAL ANALYSIS. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    DURING THE TRANSSEPTAL PORTION OF AN ATRIAL FIBRILLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION SYSTEM WAS SELECTED FOR USE. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH THE VERSACROSS SYSTEM AND DIFFICULTIES WERE NOTED DURING CROSSING OF THE SEPTUM. AN EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAM, WHEN THE EFFUSION WAS NOTED, A NON-BOSTON SCIENTIFIC ABLATION CATHETER WAS IN THE RIGHT ATRIUM. A PERICARDIOCENTISIS WAS PERFORMED WHICH STABILIZED THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    DURING THE TRANSSEPTAL PORTION OF AN ATRIAL FIBRILLATION PROCEDURE, AN EFFUSION WAS NOTED ON ICE REQUIRING A PERICARDIOCENTESIS. THE ABLATION CATHETER (TCSE) WAS IN THE RIGHT ATRIUM AND A NON ABBOTT NEEDLE (BAYLIS VERSACROSS TRANSEPTAL KIT) WAS USED AND DIFFICULTIES WERE NOTED CROSSING THE SEPTUM. A PERICARDIOCENTISIS WAS PERFORMED WHICH STABILIZED THE PATIENT. GFE 04/19/2023: D1 45/55 SHEATH WAS USED. NO RESISTANCE WAS FELT WHILE MANEUVERING THE CATHETER. 2 ATTEMPTS TO CROSS THE SEPTUM WAS NOTED WITH ICE GUIDED. ICE IMAGES WERE SUBPAR. PATIENT ANATOMY WAS NOT CHALLENGING, HOWEVER, "3 AF ABLATIONS PRIOR PROVIDED A LOT OF SCAR TISSUE ALONG FOSSA". THERE WAS DIFFICULTY IMAGING VIA ICE. LOCATION WAS THOUGHT TO BE DECENT. EFFUSION WAS NOTED POST TRANSSEPTAL AND VERSACROSS DEVICES WERE STILL IN PATIENT WHEN EFFUSION WAS OBSERVED. RF DELIVERY WAS CONFIRMED. NO PRODUCT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    DURING THE TRANSSEPTAL PORTION OF AN ATRIAL FIBRILLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION SYSTEM WAS SELECTED FOR USE. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH THE VERSACROSS SYSTEM AND DIFFICULTIES WERE NOTED DURING CROSSING OF THE SEPTUM. AN EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAM, WHEN THE EFFUSION WAS NOTED, A NON-BOSTON SCIENTIFIC ABLATION CATHETER WAS IN THE RIGHT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. FURTHER INFORMATION RECEIVED INDICATED THAT A 45 OR 55 DEGREE SHEATH WAS USED WITH A D1 DILATOR. NO RESISTANCE WAS FELT WHILE MANEUVERING THE CATHETER. TWO ATTEMPTS TO CROSS THE SEPTUM WAS NOTED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PATIENT ANATOMY WAS NOT CHALLENGING, HOWEVER, THE PHYSICIAN NOTED "THREE ATRIAL FIBRILLATION ABLATIONS PRIOR PROVIDED A LOT OF SCAR TISSUE ALONG FOSSA". THERE WAS DIFFICULTY IMAGING VIA ICE. LOCATION WAS THOUGHT TO BE DECENT. EFFUSION WAS NOTED POST TRANSSEPTAL AND THE VERSACROSS DEVICES WERE STILL IN PATIENT WHEN EFFUSION WAS OBSERVED. RADIOFREQUENCY DELIVERY WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443889 VERSACROSS ACCESS SOLUTION CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention