BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 3050541 · Received March 11, 2013

    Report

    Report Number
    1037905-2013-00094
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 9, 2013
    Manufacturer
    WILSON-COOK MEDICAL
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: AN INITIAL REVIEW OF THE PHOTOGRAPHS PROVIDED WAS CONDUCTED AND OUR EVAL CONFIRMED THE REPORT OF INTERNAL BOLSTER DETACHMENT. THE FEEDING TUBE WITH THE CLAMP ATTACHED WAS RETURNED. THE TULIP TIP WAS NOT RETURNED. OUR LAB EVAL OF THE RETURNED PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT OF INTERNAL BOLSTER DETACHMENT. A VISUAL EXAM OF THE CATHETER INDICATED THE TUBING WAS SHEARED APART LIKELY WITH FORCE AS THE EXTERNAL SECTION OF THE CATHETER APPEARED TORN AS OPPOSED TO BEING SMOOTH AND CIRCULAR. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER ASSOCIATED WITH FINISHED PRODUCT WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION IS LIKELY DUE TO THE "EXCESSIVE FORMATION OF GRANULATION TISSUE" AND THE MANUAL EXTRACTION METHOD USED TO REMOVE THE FEEDING TUBE. INSTRUCTIONS FOR USE STATES: REPLACEMENT IS RECOMMENDED EVERY THREE MONTHS USING AN EXTERNAL/TRACTION METHOD. IF THIS METHOD OF REMOVAL IS NOT POSSIBLE, ANOTHER METHOD SUCH AS ENDOSCOPIC OR SURGICAL SHOULD BE UTILIZED. EXTERNAL/TRACTION METHOD: GRASP THE GASTRIC FEEDING TUBE NEAR THE STOMA SITE. WHILE SLOWLY ROTATING THE TUBE, GENTLY PUSH 1-2 CM OF THE TUBE INTO THE STOMACH TO SEPARATE THE TUBE FROM THE STOMACH TRACT. WARNING: IF THE TUBE DOES NOT ROTATE FREELY WITHIN THE TRACT, DO NOT ATTEMPT TO USE TRACTION AS A METHOD OF REMOVAL. PRIOR TO DISTRIBUTION, ALL ENTERAL FEEDING PRODUCTS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER ASSOCIATED WITH FINISHED PRODUCT WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A REVIEW OF THE INCOMING QUALITY CONTROL RECORDS CONFIRMED THAT THE POTENTIAL LOTS INVOLVED MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT VIA THE PHYSICAL DESTRUCTIVE TENSILE TES. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED, A COOK REP HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL WAS PLACED IN (B)(6) 2012. THE PT CAME FOR A GASTROSTOMY EXCHANGE ON (B)(6) 2013. BECAUSE THE PT HAD A CARCINOMA WITH STENOSIS IN THE ESOPHAGUS, THE PHYSICIAN MADE AN ATTEMPT TO REMOVE THE GASTROSTOMY TUBE WITHOUT ENDOSCOPY CONTROL. DURING THE EXTRACTION, THE TULIP (INTERNAL DOME) WAS SEPARATED FROM THE GASTROSTOMY TUBE CATHETER AND REMAINED INSIDE THE PT. AFTER THIS COMPLICATION, THE PHYSICIAN DECIDED TO PERFORM A GASTROSCOPY PROCEDURE AND INTRODUCE A NEW GASTROSTOMY TUBE. DURING THIS PROCEDURE THE PHYSICIAN DETERMINED THAT THE TULIP (INTERNAL DOME) IS LOCATED INSIDE THE STOMACH TISSUE AND WAS DESCRIBED AS COMPLETELY OVERGROWN. THE SECOND GASTROSTOMY TUBE PLACEMENT WAS PERFORMED WITHOUT COMPLICATION. THE ORIGINAL INTERNAL DOME IS STILL INSIDE THE STOMACH TISSUE. NEXT CONTROL (GASTROSCOPY PROCEDURE) WILL BE IN TWO MONTHS TO CHECK THE ORIGINAL INTERNAL DOME AND ALSO CHECK THE PLACED GASTROSTOMY TUBE REGARDING THE POSSIBILITY OF SOME ADVERSE EFFECTS. ACCORDING TO THE INITIAL REPORTER, THE PT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO INTERNAL DOME DETACHMENT AT THIS TIME. OTHER THAN THE GASTROSCOPY TO PLACE THE GASTROSTOMY TUBE FOR THE EXCHANGE, THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO INTERNAL DOME DETACHMENT. THE PHYSICIAN HAS DECIDED TO LET THE ORIGINAL INTERNAL DOME REMAIN INSIDE THE STOMACH TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102745 OW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL W3079561

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS 165 ENDOSCOPE