BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW NON-RADIOPAQUE KARLAN BALLOON CATHETER

    MDR report key: 3911946 · Received June 30, 2014

    Report

    Report Number
    3911946
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 30, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GBZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    DURING A PLANNED CHOLECYSTECTOMY AND CHOLANGIOGRAM, THE SURGEON PLACED THE BALLOON IN THE COMMON BILE DUCT, INFLATED THE BALLOON, AND HOOKED THE DYE UP TO THE SAME PORT. SURGEON REALIZED THE DYE WAS CONNECTED TO THE WRONG PORT. HE SWITCHED PORTS AND DID THE CHOLANGIOGRAM. SURGEON INADVERTENTLY GOT A KNOT IN THE END OF THE CATHETER WHEN IT CURLED BACK ON ITSELF AFTER REACHING A BLOCKAGE WHILE INJECTING DYE INTO THE COMMON BILE DUCT. ATTEMPTED TO ASPIRATE FROM THE BALLOON PORT AND REMOVE THE BALLOON, BUT MET RESISTANCE AND BALLOON WAS STILL INFLATED. THE BALLOON COULD NOT BE REMOVED FROM THE DUCT. SURGEON CUT THE CATHETER ABOVE THE KNOT AND DISCARDED THE REMAINING PORTION OF THE CATHETER AFTER THE CASE BECAUSE THAT PORTION WAS NOT DEFECTIVE. DISTAL CATHETER PIECE REMAINED IN THE COMMON BILE DUCT; GI MEDICINE WAS CONTACTED TO DO AN ERCP AS SOON AS GI SURGEON WAS AVAILABLE. PATIENT WENT TO PACU UNTIL THE ERCP COULD BE DONE A FEW HOURS LATER, 2-INCH LONG CATHETER TIP WAS REMOVED UNEVENTFULLY IN ENDOSCOPY DURING ERCP. THE DISTAL PORTION OF THE CATHETER THAT HAD BEEN RETAINED WAS SAVED AND RETURNED TO THE MANUFACTURER. PATIENT DID WELL POSTOPERATIVELY AND WENT HOME ON POST OPERATIVE DAY 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378703 ARROW NON-RADIOPAQUE KARLAN BALLOON CATHETER LAPAROSCOPIC CHOLANGIOGRAPHY BALLOON CATHETER GBZ TELEFLEX MEDICAL * 16F14D0065

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R NO OTHER THERAPIES