BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME¿ CUTTING BALLOON¿

    MDR report key: 6033317 · Received October 17, 2016

    Report

    Report Number
    2134265-2016-09086
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    June 16, 2016
    Report Date
    September 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NWX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: 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 DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT, SUBJECTED TO POSITIVE PRESSURE AND A BALLOON PINHOLE WAS IDENTIFIED AT THE PROXIMAL END OF THE DISTAL MARKERBAND. THE MARKERBANDS, BLADES AND TIP SECTION OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THESE COMPONENTS THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT IDENTIFIED NO ISSUES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21SEP2016. IT WAS REPORTED THAT A BALLOON WAS UNABLE TO INFLATE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A 10/3.00 FLEXTOME¿ CUTTING BALLOON¿ WAS SELECTED FOR PRE DILATION. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO INFLATE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND WAS INSPECTED OUTSIDE THE PATIENT'S BODY; HOWEVER, THE BALLOON WAS STILL UNABLE TO INFLATE. THE PROCEDURE WAS COMPLETED WITH A 3.00MM NON BSC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685654 FLEXTOME¿ CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC - GALWAY H749RB4300100 19071119

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE:SION BLUE| GUIDING CATHETER:6F IL3.5| INTRODUCER SHEATH:TERUMO 6F