BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 3021655 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01742
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    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, 2134265-2013-01740, 2134265-2013-01829. IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING A CRYOPLASTY PROCEDURE AN ARTERIAL DISSECTION OCCURRED. ANGIOPLASTY WAS PERFORMED WITH A STERLING BALLOON CATHETER. BALLOON SIZES WERE CHOSEN TO EQUAL THE SIZE OF THE NEAREST NORMAL VESSEL. BALLOONS WERE INFLATED WITH 8ATMS FOR 30 - 120 SECONDS. IN CASE OF RESIDUAL STENOSIS OR HEMODYNAMICALLY RELEVANT DISSECTION, THE BALLOON WAS AGAIN INFLATED FOR 3 - 5 MINUTES. IN CASE OF PERSISTENT ANGIOPLASTY FAILURE, A SELF-EXPANDABLE STENT WAS PLACED. STENTS WERE OVERSIZED TO UP TO 1MM COMPARED TO THE REFERENCE VESSEL DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124408 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE UNK413

    Patients

    Seq Age Sex Outcome Treatment
    1 Other