BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARCATH

    MDR report key: 2983406 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01101
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    October 9, 2012
    Report Date
    January 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    DQY
    PMA / PMN Number
    K060572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BANERJEE, SUBHASH. ET AL. (2012). PILOT TRIAL OF CRYOPLASTY OR CONVENTIONAL BALLOON POST-DILATION OF NITINOL STENTS FOR REVASCULARIZATION OF PERIPHERAL ARTERIAL SEGMENTS. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. VOL. 60, NO. 15, 2012. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2013-01141 AND 2134265-2013-01142. IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING A CRYOPLASTY PROCEDURE AN ARTERIAL DISSECTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85960 POLARCATH CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - SAN JOSE UNK320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other