BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASKET, MEMORY SOFT WIRE

    MDR report key: 2182526 · Received July 25, 2011

    Report

    Report Number
    2182526
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 25, 2011
    Manufacturer
    WILSON COOK MEDICAL GI ENDOSCOPY
    Product Code
    LQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED WITH A DIAGNOSIS OF ASCENDING CHOLANGITIS. THE PHYSICIAN PERFORMED AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). DURING THE PROCEDURE, A LARGE STONE WAS NOTED IN THE CBD. THE PHYSICIAN PERFORMED A SPHINCTEROTOMY AND USED A BALLOON DEVICE TO TRY TO EXTRACT THE STONE. HE WAS UNSUCCESSFUL WITH THE BALLOON. THE PHYSICIAN THEN UTILIZED THE COOK MEMORY SOFT WIRE BASKET, CAPTURED THE STONE, THEN WAS UNABLE TO EITHER MOVE THE STONE OR REMOVE THE BASKET. THE PT THEN HAD TO BE TRANSFERRED TO ANOTHER FACILITY FOR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASKET, MEMORY SOFT WIRE MEMORY SOFT WIRE BASKET - FOUR WIRES LQC WILSON COOK MEDICAL GI ENDOSCOPY * W2567801

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R NO OTHER THERAPIES