BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEC BILIARY STENT

    MDR report key: 249412 · Received November 12, 1999

    Report

    Report Number
    6000048-1999-00031
    Event Type
    Injury
    Date Received
    November 12, 1999
    Date of Event
    September 29, 1999
    Report Date
    November 12, 1999
    Manufacturer
    MICROVASIVE ENDOSCOPY A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A STONETOME AND A GUIDEWIRE WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL EVALUATION FOUND THAT THE TRANSITION AREA WAS SEVERLY TWISTED. THE BALLOON WOULD NOT INFLATE USING A 3CC SYRINGE. LESIONS WERE DETECTED IN THE BALLOON WHEN VIEWED WITH A MICROSCOPE. A DRIED WHITE SUBSTANCE WAS ALSO DETECTED. THIS DEVICE DID NOT ORIENT PROPERLY WHEN THE HANDLE WAS ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEC BILIARY STENT BILIARY STENT FGE MICROVASIVE ENDOSCOPY A DIVISION OF BOSTON SCIENTIFIC CORP. NA 584807

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN