BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME¿ CUTTING BALLOON¿

    MDR report key: 6053290 · Received October 25, 2016

    Report

    Report Number
    2134265-2016-09376
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 29, 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

    DEVICE EVALUATED BY MANUFACTURER: 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. THE SHAFT POLYMER EXTRUSION ALSO HAD MULTIPLE KINKS. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 10/2.00 FLEXTOME¿ CUTTING BALLOON¿ WAS USED TO PRE-DILATE THE TARGET LESION. DURING THE PROCEDURE AFTER THE FLEXTOME¿ WAS DELIVERED AND CROSSED THE TARGET LESION, INFLATION WAS ATTEMPTED; HOWEVER, IT WAS NOTICED THAT THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 10/2.00 FLEXTOME¿ CUTTING BALLOON¿ WAS USED TO PRE-DILATE THE TARGET LESION. DURING THE PROCEDURE AFTER THE FLEXTOME¿ WAS DELIVERED AND CROSSED THE TARGET LESION, INFLATION WAS ATTEMPTED; HOWEVER, IT WAS NOTICED THAT THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704622 FLEXTOME¿ CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC - GALWAY H749RB4200100 18774198

    Patients

    Seq Age Sex Outcome Treatment
    1