BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARCATH

    MDR report key: 3024054 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01816
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    DQY
    PMA / PMN Number
    K060572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LOURENCO, MARCO. ET AL (2010). CRYOPLASTY FOR THE TREATMENT OF FEMOROPOPLITEAL ARTERIAL DISEASE. J VASC BRAS. 2011;10(3):205-210. 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; THEREFORE, 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

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING A CRYOPLASTY PROCEDURE A VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMOROPOPLITEAL ARTERY. DURING THE PROCEDURE A DISSECTION OCCURRED. THE PHYSICIAN TREATED THE DISSECTION WITH THE PLACEMENT OF A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127173 POLARCATH CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - SAN JOSE UNK319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other