BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARCATH

    MDR report key: 2983265 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01063
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 10, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FOSSACECA, R. ET AL. (2012). COMPARISON OF CRYOPLASTY AND CONVENTIONAL ANGIOPLASTY FOR TREATING STENOTIC-OCCLUSIVE LESIONS OF THE FEMOROPOPLITEAL ARTERIES IN DIABETIC PATIENTS: IMMEDIATE, MID-TERM AND LONG-TERM RESULTS. RADIOL MED, 117, 1176-1189. DEVICE EVALUATED BY MFR: 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

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING A CRYOPLASTY PROCEDURE A PATIENT EXPERIENCED "UNBEARABLE" PAIN PREVENTING THE COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88353 POLARCATH CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - SAN JOSE UNK320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other