BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARCATH

    MDR report key: 3023592 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01735
    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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MARIA T BASCO. LOWER EXTREMITY LIMB SALVAGE WITH CRYOPLASTY: A SINGLE CENTER COHORT STUDY. 2012 ROYAL SOCIETY OF MEDICINE PRESS. VASCULAR, VOL. 20 NO. 1, PP. 36-41, 2012 DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 VESSEL DISSECTION OCCURRED AND WAS TREATED WITH A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126528 POLARCATH CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - SAN JOSE UNK319

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention