BEUDAMED
    FDA Adverse Event Other Summary report: N

    COPE MANDRILL WIRE GUIDE

    MDR report key: 703180 · Received April 20, 2006

    Report

    Report Number
    1820334-2006-00080
    Event Type
    Other
    Date Received
    April 20, 2006
    Date of Event
    March 18, 2006
    Report Date
    March 22, 2006
    Manufacturer
    COOK INCORPORATED
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN A PT WHO REQUIRED PTCD PROCEDURE TO RELIEVE OBSTRUCTIVE JAUNDICE, THE PHYSICIAN MADE A PUNCTURE FROM THE SIDE CHEST USING A 15CM LONG 21G PUNCTURE NEEDLE, INSERTED THE PMG WIRE GUIDE BEYOND THE STENOSED AREA. THE PUNCTURE NEEDLE WAS REPLACED WITH A HAKKO BV DRAINAGE CATHETER (19G X 27CM) AND ATTEMPTED TO WITHDRAW A METAL INNER CANNULA OF THE DRAINAGE CATHETER AND THE WIRE GUIDE ALTOGHETER, DURING WHICH TIME THE DISTAL TIP OF THE WIRE GUIDE BECAME SEVERED AND LEFT WITHIN THE LOWER PART OF BILE DUCT. THE PROCEDURE WAS SUSPENDED. AS THE PT WAS ASYMPTOMATIC, HE PLANNED TO RETRIEVE THE TIP ENDOSCOPICALLY, DEPENDING UPON HOW THE PT'S FAMILY REACTED TO HIS EXPLANATION TO THEM OF THE INCIDENT. THE PHYSICIAN ASSUMED THE ADVANCEMENT OF THE WIRE GUIDE RETROFLEXED BETWEEN THE VATER'S PAPILLA AND STENOSED AREA MIGHT HAVE KINKED THE WIRE GUIDE AND DURING THE ATTEMPT TO WITHDRAW THE WIRE GUIDE AND METAL CANNULA (WHEN HE FELT RESISTANCE), THE TIP SEPARATED.

    Description of Event or Problem · 1

    INFORMATION PROVIDED TO US IN APRIL 2006 STATED THE TIP HAS NOT BEEN REMOVED AT THIS TIME; ALTHOUGH THE PHYSICIAN IS CONSIDERING REMOVING THE FRAGMENT IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COPE MANDRILL WIRE GUIDE WIRE GUIDE DQX COOK INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other