BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME® CUTTING BALLOON®

    MDR report key: 6070640 · Received November 1, 2016

    Report

    Report Number
    2134265-2016-09476
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 3, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NWX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. BLOOD WAS IDENTIFIED WITHIN THE BALLOON AND LUMEN WHICH IS EVIDENCE OF A DEVICE LEAK. 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 BLOOD THAT WAS PRESENT WITHIN THE BALLOON AND INFLATION LUMEN. THE DEVICE WAS SOAKED IN A WATER BATH AT A TEMPERATURE OF 37 DEGREES CELSIUS TO HELP SOFTEN THE BLOOD BEFORE FURTHER INFLATION ATTEMPTS WERE MADE. THE DEVICE WAS REMOVED FROM THE BATH AND THE BALLOON WAS AGAIN ATTACHED TO AN INFLATION DEVICE SUBJECTED TO POSITIVE PRESSURE AND LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE 1.5 MM DISTAL TO THE DISTAL END OF THE PROXIMAL MARKER BAND. THE HYPOTUBE WAS KINKED AT SEVERAL LOCATIONS ALONG ITS LENGTH. THE MIDSHAFT WAS ALSO KINKED AT TWO LOCATIONS. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE TIP, BLADES, OR MARKER BANDS. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 10/4.00 FLEXTOME® CUTTING BALLOON® WAS USED TO DILATE THE LESION. THE DEVICE WAS INSERTED AND BEFORE THE BALLOON WAS INFLATED, BLOOD APPEARED IN THE INFLATION DEVICE, THE BALLOON WAS BELIEVED TO HAVE RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 10/4.00 FLEXTOME® CUTTING BALLOON® WAS USED TO DILATE THE LESION. THE DEVICE WAS INSERTED AND BEFORE THE BALLOON WAS INFLATED, BLOOD APPEARED IN THE INFLATION DEVICE, THE BALLOON WAS BELIEVED TO HAVE RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720252 FLEXTOME® CUTTING BALLOON® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC - GALWAY H749CBM3400100 0018636331

    Patients

    Seq Age Sex Outcome Treatment
    1