BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSON ACUNAV 10F-64 ULTRASOUND CATHETER

    MDR report key: 7082868 · Received December 5, 2017

    Report

    Report Number
    3009498591-2017-00515
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    July 1, 2013
    Report Date
    December 5, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K071234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SIEMENS FOR EVALUATION; THEREFORE, A PHYSICAL INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    SIEMENS MEDICAL SOLUTIONS USA, INC. FOUND AN ARTICLE PUBLISHED IN THE (B)(6) TITLED, "REDUCTION OF RADIATION EXPOSURE IN CRYOBALLOON ABLATION PROCEDURES: A SINGLE-CENTRE STUDY APPLYING INTRACARDIAC ECHOCARDIOGRAPHY AND OTHER RADIOPROTECTIVE MEASURES." A TRANSTHORACIC ECHOCARDIOGRAPHY WAS PERFORMED PERI-PROCEDURE TO MEASURE THE LEFT ATRIAL (LA) DIAMETER IN A PARASTERNAL LONG-AXIS VIEW IN M-MODE, AND SIMPSON'S METHOD WAS APPLIED FOR ASSESSMENT OF THE LEFT VENTRICULAR EJECTION FRACTION (LVEF). IN THE ARTICLE, IT WAS REPORTED THAT DURING PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WHICH UTILIZED AN ACUNAV CATHETER, THERE WAS A CATHETER-INDUCED GROIN HEMATOMA WITH BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863328 ACUSON ACUNAV 10F-64 ULTRASOUND CATHETER ULTRASOUND DEVICE OBJ SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV 10F-64 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 28 MM CB ARCTIC FRONT ADVANCE| ACHIEVETM MAPPING CATHETER| ACUSONCYPRESSTM| FLEXCATH| QUADRIPOLAR CATHETER