BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2CM PERIPHERAL CUTTING BALLOON

    MDR report key: 9163118 · Received October 7, 2019

    Report

    Report Number
    2134265-2019-12108
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 19, 2019
    Report Date
    November 11, 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

    PREMARKET UPDATED TO K070951. 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. 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 AND LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE DETECTED APPROXIMATELY 9MM DISTAL OF THE DISTAL 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 A BALLOON RUPTURE OCCURRED. A 5.00MM / 2.0CM / 90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, AT INFLATION, IT WAS NOTED THAT THE BALLOON WAS RUPTURED AT10 ATMOSPHERE (ATM) IN 30 SECONDS. HOWEVER, IT WAS FURTHER REPORTED THAT THE DEVICE WAS COMPLETELY AND SIMPLY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BALLOON. NO PATIENT COMPLICATIONS WAS REPORTED. PATIENT WAS GOOD POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.00MM / 2.0CM / 90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, AT INFLATION, IT WAS NOTED THAT THE BALLOON WAS RUPTURED AT10 ATMOSPHERE (ATM) IN 30 SECONDS. HOWEVER, IT WAS FURTHER REPORTED THAT THE DEVICE WAS COMPLETELY AND SIMPLY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BALLOON. NO PATIENT COMPLICATIONS WAS REPORTED. PATIENT WAS GOOD POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957810 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC CORPORATION 24630 0023621630

    Patients

    Seq Age Sex Outcome Treatment
    1