BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER?

    MDR report key: 4863548 · Received June 23, 2015

    Report

    Report Number
    2134265-2015-03903
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K112697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2015-03899. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING ATHERECTOMY USING A JETSTREAM¿ ATHERECTOMY SYSTEM,, A 7.0X150MM, 135CM CHARGER¿ BALLOON CATHETER WAS USED FOR POST ANGIOPLASTY. HOWEVER, ON THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED LONGITUDINALLY. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT AND WAS EXCHANGED WITH ANOTHER 7.0X200MM, 135CM CHARGER¿ BALLOON CATHETER WHICH WAS INFLATED TWICE AT 8ATMOSPHERES. HOWEVER, ON THE THIRD INFLATION AT 8 ATMOSPHERES, THE SECOND BALLOON ALSO RUPTURED LONGITUDINALLY. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405524 CHARGER? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939206072010 0015832927

    Patients

    Seq Age Sex Outcome Treatment
    1