BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER¿

    MDR report key: 3041982 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02205
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-02204. IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED PROXIMAL POPLITEAL SUPERFICIAL FEMORAL ARTERY (SFA). A CHARGER BALLOON CATHETER WAS USED TO DILATE THE LESION BUT THERE WAS ONE SMALL SECTION THAT WAS RESISTANT CAUSING THE BALLOON TO RUPTURE LONGITUDINALLY DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED INTACT AND EXCHANGED FOR A SECOND CHARGER BALLOON CATHETER THAT RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE SECOND CHARGER BALLOON WAS ALSO REMOVED INTACT. AN UNSPECIFIED STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH A THIRD CHARGER BALLOON CATHETER WHICH WAS USED TO POST DILATE THE AREA AND OPEN THE LESION. NO COMPLICATION WERE REPORTED AND PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144735 CHARGER¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939206061510 14839115

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR