BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERISIGHT PRO INTRACARDIAC ECHOCARDIOGRAPHY CATHETER

    MDR report key: 19986574 · Received August 14, 2024

    Report

    Report Number
    3008363989-2024-00049
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 14, 2024
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    UDI-DI
    00845225003036
    PMA / PMN Number
    K200812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURE¿S POLICY. BLOCKS A2-A6: NO INFORMATION AVAILABLE. BLOCKS B6 & B7: NO INFORMATION AVAILABLE. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. THE VERISIGHT CATHETER WAS DISCARDED AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BLOCK H6: PER THE IFU, CARDIAC PERFORATION IS A KNOWN ADVERSE EFFECT OF THE PROCEDURE. BLOCKS H7, H9, & H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VERISIGHT CATHETER WAS USED IN A THERAPEUTIC EP STRUCTURAL HEART PROCEDURE. THE CATHETER WAS DELIVERED OVER A NON-PHILIPS GUIDEWIRE THAT WAS PLACED NEAR THE LEFT ATRIAL APPENDAGE (LAA). AFTER THE ATRIAL SEPTUM WAS DILATED, THE CATHETER WAS ADVANCED TO THE LEFT ATRIUM WHEN THE PATIENT¿S BLOOD PRESSURE DROPPED. AN EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND A MICROSCOPIC PERFORATION WAS NOTED IN THE LAA. THE PATIENT WAS TRANSFERRED TO THE OR TO SURGICALLY REPAIR THE PERFORATION. THIS ADVERSE EVENT IS BEING SUBMITTED FOR THE VERISIGHT CATHETER, IN USE IN THE AREA WHEN A PERFORATION OCCURRED, REQUIRING SURGICAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE VERISIGHT CATHETER DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362704 VERISIGHT PRO INTRACARDIAC ECHOCARDIOGRAPHY CATHETER CATHETER, IMAGAING, ULTRASOUND OBJ VOLCANO CORPORATION VSICE3D 0303103900 00845225003036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening 9F: INTRODUCER SHEATH, UNK MFG| BOSTON SCIENTIFIC: VERSACROSS GUIDEWIRE, SIZE UNK| PHILIPS: EPIQ ULTRASOUND SYSTEM