BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARCATH

    MDR report key: 3021695 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01740
    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
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DIAZ, MARIA LOURDES. ET AL. (2010) CRYOPLASTY VERSUS CONVENTIONAL ANGIOPLASTY IN FEMOROPOPLITEAL ARTERIAL RECANALIZATION: 3-YEAR ANALYSIS OF REINTERVENTION-FREE SURVIVAL BY TREATMENT RECEIVED. SPRINGER SCIENCE+BUSINESS MEDIA, LLC AND THE CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE. (CIRSE). 2010 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 2134265-2013-01830, 2134265-2013-01742, 2134265-2013-01829. IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING A CRYOPLASTY PROCEDURE, AN ARTERIAL DISSECTION OCCURRED. CRYOPLASTY BALLOON SIZES WERE CHOSEN TO EQUAL THE NEAREST NORMAL-APPEARING VESSEL LUMEN. ONCE THE BALLOON WAS ADVANCED INTO THE LESION, THE PROCEDURE WAS CARRIED OUT WITH THE POLAR CATH CRYOPLASTY SYSTEM ACCORDING TO THE INSTRUCTIONS FOR USE. THE BALLOON WAS MANUALLY DEFLATED AND REPOSITIONED OR REMOVED. MULTIPLE RUNS OF CRYOPLASTY WERE ALLOWED (MAXIMUM OF FOUR), WITH EACH INFLATION. IN CASE OF 30% RESIDUAL STENOSIS OR LUMINAL NARROWING BY DISSECTION, A SELF-EXPANDABLE STENT WAS IMPLANTED . STENTS WERE OVERSIZED TO UP TO 1MM COMPARED TO THE REFERENCE VESSEL DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124258 POLARCATH CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - SAN JOSE UNK319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other