BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIEWFLEX¿ICE CATHETER

    MDR report key: 23675465 · Received November 28, 2025

    Report

    Report Number
    2030404-2025-00062
    Event Type
    Injury
    Date Received
    November 28, 2025
    Date of Event
    September 17, 2025
    Report Date
    November 28, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF PERICARDIAL EFFUSION WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    FOLLOWING A SUCCESSFUL ATRIAL FIBRILLATION PROCEDURE, AFTER REMOVAL OF THE CATHETERS AND SHEATHS FROM THE PATIENT'S BODY, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM WAS USED TO OBSERVE THE POTENTIAL FOR PERICARDIAL EFFUSION. PERICARDIAL EFFUSION WAS CONFIRMED AND IT WAS ATTEMPTED TO PERFORM A PERICARDIOCENTESIS TO RELEASE THE FLUID BUILDUP SURROUNDING THE CARDIAC TISSUE POSTERIORLY TO THE HEART AS WELL AS ANTERIOR TO THE RIGHT VENTRICLE. ANOTHER ATTENDING PHYSICIAN WAS CALLED IN TO AID IN THE PLACEMENT OF WIRES NEEDED TO PERFORM THE FLUID RELEASE TAP. THE WIRES WERE PLACED SUCCESSFULLY AND APPROXIMATELY 2L OF BLOOD WAS WITHDRAWN FROM THE EFFUSION AND RECYCLED THROUGH THE GUIDE THAT WAS PLACED IN THE PATIENT'S GROIN. THE PATIENT STABILIZED AFTER SEVERAL ROUNDS OF THIS RECYCLING TECHNIQUE. THE PATIENT WAS MOVED TO THE ICU TO BE MONITORED AND HAS SINCE FULLY RECOVERED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PHYSICIAN ALLEGES THAT A PERFORATION COULD HAVE BEEN MADE IN THE LEFT ATRIUM AT SOME POINT DURING THE PROCEDURE FOR THE PERICARDIAL EFFUSION TO BE PRESENT. AFTER FURTHER FOLLOW UP WITH THE PHYSICIAN, THE CONCLUSION WAS THAT THE PRODUCT RESPONSIBLE FOR THE PERFORATION DURING THE CASE WAS THE VIEWFLEX ICE CATHETER NOT THE TACTIFLEX SE. AT THE TIME IT WAS DIFFICULT TO DETERMINE WHICH PRODUCT WAS RESPONSIBLE FOR THE EVENT, BUT IN HINDSIGHT THE PERFORATION AND LATER EFFUSION WAS PRIMARILY LOCATED AROUND THE RIGHT VENTRICLE WHERE THE VIEWFLEX ICE CATHETER WAS DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2400310 VIEWFLEX¿ICE CATHETER SYSTEM, SIGNAL ISOLATION DRJ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention TACTICATH¿ ABLATION CATHETER, SE