BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1061331 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00713
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    UNK
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC PRODUCT INFO IS UNKNOWN AND THE COMPLAINANT HAS INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A DEVICE EVAL, DEVICE HISTORY RECORD (DHR) REVIEW, SIMILAR COMPLAINT SEARCH, AND COMPLAINT TREND REPORT REVIEW ARE NOT POSSIBLE. NO FURTHER INFO IS AVAILABLE REGARDING THE SUSPECT DEVICE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT ADDRESSES ONE OF TWO DEVICES USED DURING THE PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2008-00677 FOR A DESCRIPTION OF THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BILIARY STENT (IT IS UNCONFIRMED IF BSC IS THE MANUFACTURER) WAS USED DURING A STENT PLACEMENT PROCEDURE IN 2008 (PATIENT GENDER, AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE DEVICE WAS "BEING USED TO RETRIEVE STONES AND TO DEPLOY STENT IN BILIARY." AND, "AFTER RETRIEVAL OF STONES, THIS GUIDEWIRE WAS INSERTED FROM THE JAG TIP TO DEPLOY THE STENT IN BILIARY. HOWEVER, WHEN IT WAS INTRODUCED THE STENT DELIVERY SYSTEM OVER THE GUIDEWIRE, IT GOT STUCK AT THE DREAM TIP. BECAUSE WHEN IT WAS EXAMINED THE LOCATION OF THE STUCK AND IT WAS FOUND TO BE EXPOSED THE CORE WIRE, THE STENT DELIVERY SYSTEM WAS ATTEMPTED TO REMOVE OUTSIDE BODY. HOWEVER, WHEN IT WAS TRIED TO REMOVE THE SYSTEM, IT WAS FELT SEVERE RESISTANCE. DUE TO THE RESISTANCE, IT WAS RELEASED THE STENT ACCIDENTALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK FGE UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other