BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA ICE PLUS¿

    MDR report key: 6795253 · Received August 15, 2017

    Report

    Report Number
    2134265-2017-07872
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    July 14, 2017
    Report Date
    July 17, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DXK
    PMA / PMN Number
    K160173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PERICARDIAL EFFUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT AND LEFT ATRIUM. DURING AND ATRIAL FIBRILLATION ABLATION PROCEDURE AND ULTRA ICE PLUS¿ WAS USED. THE PHYSICIAN FELT THE ICE IMAGES HAD POOR QUALITY AND THE PHYSICIAN DESCRIBED THE PATIENT AS HAVING A THICK SEPTUM AND THOUGHT THAT MIGHT HAVE CONTRIBUTED TO THE POOR IMAGES. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED SURGICAL INTERVENTION. THEY ABORTED THE PROCEDURE DUE TO THIS EVENT. PATIENT IS NOW STABLE AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574471 ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC DXK BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00499120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention