BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME¿ CUTTING BALLOON¿

    MDR report key: 6015480 · Received October 10, 2016

    Report

    Report Number
    2134265-2016-08985
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 15, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    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 LOCATED AT THE DISTAL EDGE OF THE PROXIMAL MARKER BAND. THE HYPOTUBE WAS KINKED AT SEVERAL LOCATIONS ALONG ITS LENGTH. 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 MARKERBANDS. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% IN-STENT RESTENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CIRCUMFLEX ARTERY (RCA). A 10/3.00 FLEXTOME¿ CUTTING BALLOON¿ WAS SELECTED FOR PRE-DILATION. DURING THE 1ST INFLATION, THE BALLOON RUPTURED AT 4 ATM. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND A PINHOLE RUPTURE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 10/3.25 FLEXTOME BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% IN-STENT RESTENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CIRCUMFLEX ARTERY (RCA). A 10/3.00 FLEXTOME¿ CUTTING BALLOON¿ WAS SELECTED FOR PRE-DILATION. DURING THE 1ST INFLATION, THE BALLOON RUPTURED AT 4 ATM. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND A PINHOLE RUPTURE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 10/3.25 FLEXTOME BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665743 FLEXTOME¿ CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC - GALWAY H749RB4300100 0018876032

    Patients

    Seq Age Sex Outcome Treatment
    1