BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME OTW CUTTING BALLOON

    MDR report key: 1030531 · Received April 17, 2008

    Report

    Report Number
    2134265-2008-01128
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE RESTENOSED LESION BEING TREATED WAS LOCATED IN A LONG STENT IN THE PROTECTED LEFT MAIN ARTERY (LM). THE JL4 6F GUIDE CATHETER AND UNSPECIFIED WIRE WERE ADVANCED WITHOUT DIFFICULTY. THE LESION WAS FIRST TREATED WITH TWO INFLATIONS WITH A 2.5 CUTTING BALLOON WITHOUT DIFFICULTY. THE 4.0 FLEXTOME OTW CUTTING BALLOON WAS ADVANCED TO THE LESION WITHOUT DIFFICULTY, AND INFLATED ONE TIME "NOT HIGHER THAN LABEL" SUCCESSFULLY. THE PHYSICIAN THEN DEFLATED THE FLEXTOME OTW BALLOON AND ATTEMPTED TO WITHDRAW IT INTO THE GUIDE CATHETER, AND RAN INTO DIFFICULTIES. HE THEN REALIZED THAT THE FLEXTOME OTW BALLOON WAS ONLY DEFLATED APPROX 50%. HE WAS ABLE TO MOVE THE GUIDE CATHETER AND BALLOON OUT OF THE LM, AND THE PT REMAINED HEMODYNAMICALLY STABLE. HE THEN ATTEMPTED TO SHIFT THE GUIDE CATHETER AND REDEFLATE THE BALLOON; HOWEVER, HE WAS NOT SUCCESSFUL IN WITHDRAWING THE BALLOON INTO THE GUIDE CATHETER. HE THEN REMOVED ALL DEVICES, GUIDE WIRE, GUIDE CATHETER, AND BALLOON, FROM THE BODY AS ONE UNIT WITHOUT INCIDENT. HE FOUND NO DAMAGE ON THE FLEXTOME OTW BALLOON, HOWEVER, IT WAS STILL PARTIALLY INFLATED. THE GUIDE CATHETER WAS SLIGHTLY INVAGINATED. THE PT DID NOT EXPERIENCE ANY SYMPTOMS DURING THIS EVENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME OTW CUTTING BALLOON LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CBO340015 EH5487

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDANT COPILOT INFLATION DEVICE