BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME® CUTTING BALLOON®

    MDR report key: 3140370 · Received May 31, 2013

    Report

    Report Number
    2134265-2013-04155
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DEVICE RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED SHAFT STRETCHING FROM 24.6CM TO 35.1CM FROM THE CATHETER TIP. THE SHAFT WAS ALSO TWISTED. THIS IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DEVICE DURING USE. A VISUAL EXAMINATION CONFIRMED THE INNER LUMEN HAD DETACHED. THE LENGTH OF THE GAP FROM THE INNER LUMEN AND THE DISTAL BOND WAS <0.5MM. MARKERBAND POSITIONING WAS ACCEPTABLE. EACH MARKERBAND WAS OUTSIDE OF THE BLADE WORKING LENGTH. A MICROSCOPIC EXAMINATION OF THE BLADES FOUND NO ISSUES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON. 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS DEFECTIVE OUT OF THE PACKAGE. DURING UNPACKING OF THE DEVICE IT WAS NOTED THAT THE MARKER BANDS OF A 4.0 X 15MM FLEXTOME CUTTING BALLOON CATHETER WERE NOT LINED UP WITH THE SHOULDER OF THE BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS DEFECTIVE OUT OF THE PACKAGE. DURING UNPACKING OF THE DEVICE IT WAS NOTED THAT THE MARKER BANDS OF A 4.0 X 15MM FLEXTOME CUTTING BALLOON CATHETER WERE NOT LINED UP WITH THE SHOULDER OF THE BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS DEFECTIVE OUT OF THE PACKAGE. DURING UNPACKING OF THE DEVICE IT WAS NOTED THAT THE MARKER BANDS OF A 4.0 X 15MM FLEXTOME CUTTING BALLOON CATHETER WERE NOT LINED UP WITH THE SHOULDER OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242152 FLEXTOME® CUTTING BALLOON® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749CBM3400150 0015777251

    Patients

    Seq Age Sex Outcome Treatment
    1