BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSON ACUNAV 10F ULTRASOUND CATHETER

    MDR report key: 7075328 · Received December 1, 2017

    Report

    Report Number
    3009498591-2017-00508
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    March 1, 2016
    Report Date
    December 1, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K071234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 HEART RHYTHM. 2016 JUN TITLED: "IS TRANSESOPHAGEAL ECHOCARDIOGRAM MANDATORY IN PATIENTS UNDERGOING ABLATION OF ATRIAL FIBRILLATION WITH UNINTERRUPTED NOVEL ORAL ANTICOAGULANTS? RESULTS FROM A PROSPECTIVE MULTICENTER REGISTRY." IN THE ARTICLE, IT WAS REPORTED THAT A PATIENT HAD A STROKE AFTER USING AN ACUNAV CATHETER DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE. ATTEMPTS WERE MADE VIA EMAIL TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED PHENOMENON AND PATIENT OUTCOME BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855619 ACUSON ACUNAV 10F ULTRASOUND CATHETER ULTRASOUND DEVICE OBJ SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV 10F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening 3.5MM THERMOCOOL IRRIGATING TIP CATHETER| HEPARIN| LASSO CIRCULAR MAPPING CATHETER