BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME¿ CUTTING BALLOON¿

    MDR report key: 6199109 · Received December 22, 2016

    Report

    Report Number
    2134265-2016-11966
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 7, 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. 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 INFLATION LUMEN WHICH IS EVIDENCE OF A DEVICE LEAK. THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED AT THE DISTAL EDGE OF THE DISTAL MARKER BAND. AN EXAMINATION OF THE BALLOON MATERIAL AND MARKERBANDS IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THIS COMPLAINT. A VISUAL AND MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE TIP OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. THE HYPOTUBE WAS KINKED AT SEVERAL LOCATIONS ALONG ITS LENGTH. 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 TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SECOND RIGHT POSTEROLATERAL (RPL) ARTERY. A 10/2.5 FLEXTOME¿ CUTTING BALLOON¿WAS USED FOR PRE-DILATION. IT WAS NOTED THAT THERE WAS RESISTANCE ENCOUNTERED DURING INSERTION. THE BALLOON WAS THEN INITIALLY INFLATED AT 6ATM AND THE 2ND INFLATION WAS AT 8ATM. DURING THE THIRD INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SECOND RIGHT POSTEROLATERAL (RPL) ARTERY. A 10/2.5 FLEXTOME¿ CUTTING BALLOON¿WAS USED FOR PRE-DILATION. IT WAS NOTED THAT THERE WAS RESISTANCE ENCOUNTERED DURING INSERTION. THE BALLOON WAS THEN INITIALLY INFLATED AT 6ATM AND THE 2ND INFLATION WAS AT 8ATM. DURING THE THIRD INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851451 FLEXTOME¿ CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC - GALWAY H749RB4225100 0019009510

    Patients

    Seq Age Sex Outcome Treatment
    1