BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2CM PERIPHERAL CUTTING BALLOON

    MDR report key: 8906360 · Received August 19, 2019

    Report

    Report Number
    2134265-2019-09868
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G5: PREMARKET: UPDATED TO K070951. DEVICE EVALUATED BY THE MANUFACTURER:THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THERE WAS BLOOD IN THE BALLOON MATERIAL WHICH SUGGESTS THAT THERE IS A LEAK IN THE DEVICE. 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 DETECTED APPROXIMATELY AT THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. AN EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THIS COMPLAINT. A VISUAL AND MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE BLADES. ALL BLADES WERE INTACT AND FULLY BONDED TO THE BALLOON SURFACE. NO DAMAGE OR ANY ISSUES WERE NOTED WITH THE BLADES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A VISUAL AND MICROSCOPIC EXAMINATION OF THE MARKERBANDS WAS COMPLETED. THERE WAS NO BURRS OR UNEVEN EDGES OBSERVED ON THE MARKERBANDS. NO DAMAGE OR ANY ISSUES WERE NOTED WITH THE MARKERBANDS THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE SHAFT WHICH MAY HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. NO ISSUES WERE NOTED WITH THE TIP SECTION OF THE DEVICE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 6.00MM / 2.0CM / 135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON SECOND INFLATION AT UNKNOWN PRESSURE. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 6.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON SECOND INFLATION AT UNKNOWN PRESSURE. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699219 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC CORPORATION 24634 0023091843

    Patients

    Seq Age Sex Outcome Treatment
    1