BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARCATH

    MDR report key: 3020910 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01799
    Event Type
    Injury
    Date Received
    March 26, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BOSIERS, M. ET AL. (2010). THE USE OF THE CRYOPLASTY TECHNIQUE IN THE TREATMENT OF INFRAPOPLITEAL LESIONS FOR CRITICAL LIMB ISCHEMIA PATIENTS IN A ROUTINE HOSPITAL SETTING: ONE-YEAR OUTCOME OF THE CRYOPLASTY CLIMB REGISTRY. THE JOURNAL OF CARDIOVASCULAR SURGERY; 2010;51:193-202. 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; 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

    SAME CASE AS 2134265-2013-01744, 2134265-2013-01798, 2134265-2013-01802, 2134265-2013-01801, 2134265-2013-01805, 2134265-2013-01806, 2134265-2013-01810, 2134265-2013-01811, 2134265-2013-01812, 2134265-2013-01813, 2134265-2013-01814. IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING A CRYOPLASTY PROCEDURE A FLOW LIMITING DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE INFRAPOPLITEAL ARTERY. THE DISSECTION WAS TREATED WITH THE PLACEMENT OF A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124519 POLARCATH CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - SAN JOSE UNK319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other