BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME¿ CUTTING BALLOON¿

    MDR report key: 2181721 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03242
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: A VISUAL EXAMINATION OF THE DEVICE IDENTIFIED SOLIDIFIED BLOOD WITHIN THE BALLOON AND INFLATION LUMEN. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS SUCCESSFULLY INFLATED TO ITS RATED BURST PRESSURE. A MICROSCOPIC EXAMINATION OF THE MARKERBANDS IDENTIFIED NO DAMAGE. THE SPACING FROM THE DISTAL MARKERBAND TO THE PROXIMAL MARKERBAND WAS ALIGNED PER FLEXTOME CORONARY CUTTING BALLOON PRODUCT SPECIFICATION. A VISUAL AND MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE BALLOON OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. MANDREL INSERTION THROUGH THE LUMEN REVEALED NO RESTRICTIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.BSC ID A00290265 / TW # 2053049

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, MARKER BAND ISSUES WERE NOTED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. DURING THE PROCEDURE, AFTER INFLATING THE 10MM X 3.50MM FLEXTOME MR CUTTING BALLOON, THE PHYSICIAN OBSERVED THE POSITION BETWEEN THE MARKER BAND AND THE BALLOON TO BE "OUT OF ALIGNMENT." THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT STATUS WAS RECORDED AS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, MARKER BAND ISSUES WERE NOTED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. DURING THE PROCEDURE, AFTER INFLATING THE 10MM X 3.50MM FLEXTOME MR CUTTING BALLOON, THE PHYSICIAN OBSERVED THE POSITION BETWEEN THE MARKER BAND AND THE BALLOON TO BE "OUT OF ALIGNMENT." THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT STATUS WAS RECORDED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME¿ CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749RB4350100 0013913669

    Patients

    Seq Age Sex Outcome Treatment
    1