BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME¿ CUTTING BALLOON¿

    MDR report key: 6060878 · Received October 27, 2016

    Report

    Report Number
    2134265-2016-09417
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    June 30, 2016
    Report Date
    September 30, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NWX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON HAD BEEN SUBJECTED TO POSITIVE PRESSURE AND DEFLATED PRIOR TO RETURN. THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND POSITIVE PRESSURE WAS APPLIED IN AN ATTEMPT TO INFLATE THE BALLOON. THE BALLOON COULD NOT BE INFLATED DUE TO THE PRESENCE OF SOLIDIFIED SALINE SOLUTION PRESENT WITHIN THE BALLOON AND INFLATION LUMEN. THE DEVICE WAS SOAKED IN A WATER BATH AT A TEMPERATURE OF 37 DEGREES TO HELP SOFTEN THE SOLIDIFIED SOLUTION BEFORE FURTHER INFLATION ATTEMPTS WERE MADE. THE DEVICE WAS REMOVED FROM THE BATH AND THE BALLOON WAS AGAIN ATTACHED TO AN INFLATION DEVICE. IT WAS NOTED THAT THE BALLOON INFLATED TO THE RATED BURST PRESSURE OF 12 ATMOSPHERES VERY SLOWLY. THE BALLOON DID NOT DEFLATE WHEN NEGATIVE PRESSURE WAS APPLIED. THE MARKERBANDS, BLADES AND TIP SECTION OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED. THERE WERE NO ISSUES WITH THE TIP OR BLADES, HOWEVER, IT WAS NOTED THAT THE PROXIMAL MARKERBAND AND THE INNER WERE FLATTENED. A FURTHER EXAMINATION OF THE INNER FOUND THAT THE INNER WAS FLATTENED AT VARIOUS LOCATIONS ALONG THE DEVICE. AN EXAMINATION OF THE PROXIMAL WELD SITE FOUND NO SIGNS OF FOCAL NECKING. THE PROXIMAL WELD SITE WAS MEASURED AT 0.037 INCHES USING LASER MIKE SHAMROCK NUMBER 14862. AS A RESULT THE PROXIMAL WELD SITE IS WITHIN SPECIFICATION. NO ISSUES WERE NOTED WITH THE ACTUAL DEVICE WHICH COULD HAVE RESULTED IN THE DEFLATE ISSUE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-SEP-2016. IT WAS REPORTED THAT THE BALLOON INFLATION FAILED. THE TARGET LESION WAS LOCATED AT THE LEFT CIRCUMFLEX ARTERY. A 10/3.50 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING TESTING, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE AFTER OPENING FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE BALLOON COULD NOT BE DEFLATED EVEN WHEN APPLYING NEGATIVE PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711909 FLEXTOME¿ CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC - GALWAY H749RB4350100 0018664259

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR