BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER?

    MDR report key: 4243638 · Received November 11, 2014

    Report

    Report Number
    2134265-2014-06818
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K112697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR 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 FACTOR. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-06819. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 10.0MMX40MMX135CM STERLING¿ BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PREDILATION. THE BALLOON WAS FIRST INFLATED AT 6 ATMOSPHERES HOWEVER IT RUPTURED AT 6 ATMOSPHERES ON THE SECOND INFLATION. THE DEVICE WAS EXCHANGED TO A 12.0MM X 40MM, 75CM CHARGER¿ BALLOON CATHETER. THE BALLOON WAS FIRST INFLATED AT 8ATMOSPHERES AND PREDILATION WAS COMPLETED. THEN A 16X90CM AND A 16X60CM WALLSTENT WERE DEPLOYED IN THE LESION IN AN OVERLAPPING MANNER. THEN POST DILATION OF THE RECENTLY IMPLANTED STENTS WAS PERFORMED PER NORMAL PROCEDURE. THE SAME 12.0MM X 40MM, 75CM CHARGER¿ BALLOON CATHETER WAS ADVANCED THROUGH THE STENTS. THE BALLOON WAS INFLATED AT 8 ATMOSPHERES HOWEVER IT RUPTURED ON THE FIRST INFLATION. THE DEVICE WAS THEN EXCHANGED TO A 14-4/5.8/120 XXL¿ VASCULAR BALLOON CATHETER. THE BALLOON WAS INFLATED THREE TIMES AT NOMINAL PRESSURE. ON THE THIRD INFLATION, IT WAS NOTED THAT THE BALLOON HAD RUPTURED AT NOMINAL PRESSURE HOWEVER THE BALLOON WAS ABLE TO PROPERLY DILATE THE STENTS AND THE PROCEDURE WAS COMPLETED. THE THREE BALLOON CATHETERS WERE COMPLETELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727874 CHARGER? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939206120470 15676905

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT:16X90CM AND 16X60CM WALLSTENT