BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIMBERLY CLARK MIC G INTRODUCER KIT

    MDR report key: 1120768 · Received August 15, 2008

    Report

    Report Number
    9611594-2008-00006
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 15, 2008
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WILL BE SENT FOR EVAL. INVESTIGATION IS IN PROCESS. THE CURRENT DIRECTIONS FOR USE STATES THAT "WHILE HOLDING THE SERIAL DILATOR STATIONARY, GRASP THE NEXT DILATOR SLEEVE AND WITH FIRM DOWNWARD PRESSURE AND A CLOCKWISE/ COUNTER CLOCKWISE TWISTING MOTION ADVANCE THE SUBSEQUENT DILATOR INTO THE STOMA TRACT. SLIDE THE SEGMENT FORWARD UNTIL A PHYSICAL STOP IS FELT." A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL RELEVANT INFO BECOMES AVAILABLE. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE MFR BY A KIMBERLY-CLARK SALES REP THAT AN INTERVENTIONAL RADIOLOGIST WAS USING THE 20 FR PERCUTANEOUS INTRODUCER KIT TO PLACE A G-TUBE. THE DILATOR SLEEVES WERE PUSHED BEYOND THE PHYSICAL STOPS OF THE SLEEVES WERE PUSHED BEYOND THE PHYSICAL STOPS OF THE SLEEVES SEPARATING THE DILATOR SLEEVES FROM THE DILATOR CORE. AS A RESULT, SOME OF THE SERIAL DILATOR SLEEVES REMAINED WITHIN THE PEAL-AWAY SHEATH DURING REMOVAL OF THE DILATOR CORE. DURING PLACEMENT OF THE G-TUBE THROUGH THE PEEL-AWAY SHEATH, THE DILATOR SLEEVES WERE PUSHED INTO THE PT'S STOMACH. DUE TO THE PT'S PRE-EXISTING CONDITION REMOVAL VIA ENDOSCOPY WAS NOT AVAILABLE; THEREFORE, SURGERY WAS REQUIRED TO REMOVE THE DILATOR SLEEVES FROM THE STOMACH. THE USER REPORTED THAT THE PT IS DOING FINE AT THIS TIME. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFO THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK MIC G INTRODUCER KIT 20F PERCUTANEOUS INTRODUCER KIT KNT AVENT SA DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention