BEUDAMED
    FDA Adverse Event Death Summary report: N

    PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 2010476 · Received March 4, 2011

    Report

    Report Number
    1037905-2011-00125
    Event Type
    Death
    Date Received
    March 4, 2011
    Date of Event
    December 28, 2010
    Report Date
    February 4, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL FACILITY PROVIDED INFO ON THIS EVENT TO FDA VIA SUBMISSION OF A MEDWATCH REPORT. REFERENCE REPORT NUMBER (B)(4) FOR INFO RELATED TO THE SAME EVENT THAT WAS PROVIDED TO FDA BY THE MEDICAL FACILITY. EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED COULD NOT BE DETERMINED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. IN THE PAST TWELVE MONTHS, THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSIONS: AT THIS TIME IS UNK IF AN AUTOPSY HAS BEEN PERFORMED. THE CAUSE OF DEATH LISTED ON THE AUTOPSY REPORT (IF ANY) IS UNK AT THIS TIME. TUBE DISLODGEMENT AND MIGRATION ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL COMPLICATIONS ASSOCIATED WITH PLACEMENT AND USE OF A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE. PERITONITIS, SEPTIC SHOCK, PNEUMOPERITONEUM, PURULENT DRAINAGE AND STOMA LEAKAGE ARE ALSO LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL COMPLICATIONS ASSOCIATED WITH PLACEMENT AND USE OF A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO SLOWLY PULL THE DILATING PORTION OF THE GASTROSTOMY TUBE THROUGH THE ABDOMINAL INCISION. THE USER IS THEN INSTRUCTED TO BRING THE TULIP TIP IN CONTACT WITH THE ABDOMINAL WALL, CAREFULLY AVOIDING EXCESS TENSION. IF EXCESS TENSION WAS APPLIED TO THE GASTROSTOMY TUBE DURING PLACEMENT, THIS COULD CONTRIBUTE TO TUBE DISLODGEMENT. THE INSTRUCTIONS FOR USE INDICATE THIS TUBE HAS BEEN DESIGNED FOR REMOVAL USING THE EXTERNAL/TRACTION METHOD. (THE EXTERNAL/TRACTION METHOD INCLUDES APPLYING STEADY TRACTION TO THE TUBE UNTIL THE INTERNAL DOME EMERGES THROUGH THE ABDOMINAL WALL). MOMENTARY "COLLAPSING" OF THE INTERNAL DOME ALLOWS THE FEEDING TUBE TO SAFELY EXIT THE PT. TO KEEP THE TUBE IN PLACE BEFORE IT IS READY TO BE REMOVED, THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO SLIDE THE BOLSTER OVER THE FEEDING TUBE. THE INSTRUCTIONS FOR USE WARN THE USER THAT THE BOLSTER SHOULD REST GENTLY ON THE SKIN SURFACE. EXCESSIVE TRACTION ON THE TUBE MAY CAUSE MOVEMENT OF THE FEEDING TUBE FROM THE ORIGINAL PLACEMENT POSITION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO NOTE THE CENTIMETER MARKING ON THE TUBE THAT IS CLOSEST TO THE BOLSTER AND RECORD IT ON THE PATIENT'S CHART AND ON THE PT INFO SHEET IN THE PT CARE MANUAL (THE PT CARE MANUAL ENCLOSED IN THE KIT IS INTENDED AS A REFERENCE FOR THE CAREGIVERS OF THE PT). THE INSTRUCTIONS FOR USE INFORM THE USER THAT IT IS ESSENTIAL FOR THE PT ARE MANUAL TO REMAIN WITH THE PT AND BE EXPLAINED TO ALL PEOPLE RESPONSIBLE FOR THE CARE OF THE PT. THE PT CARE MANUAL INSTRUCTS THE CAREGIVER TO MAKE NOTE OF THE CENTIMETER MARKING CLOSEST TO THE TOP OF THE EXTERNAL BOLSTER BEFORE FEEDING TO CONFIRM THE TUBE IS IN THE PROPER POSITION. THIS ACTIVITY WILL ASSIST THE CAREGIVER IN DETERMINING IF THE TUBE HAS DISLODGED OR MIGRATED. IF THESE DIRECTIONS ARE NOT FOLLOWED, THIS COULD LEAD TO UNDETECTED TUBE DISLODGEMENT. PRIOR TO DISTRIBUTION, ALL LOTS OF PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THIS INVOLVES AN INHERENT RISK OF FEEDING TUBE PLACEMENT AND USAGE. THIS OBSERVATION REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DAY 1: A COOK GASTROSTOMY TUBE (PEG-24-PULL-S) WAS PLACED SOMETIME IN (B)(6) 2010 AFTER ULTRASOUND CONFIRMED NO ASCITES (EXCESS FLUID IN THE PERITONEAL CAVITY). DAY 2: FEEDING BEGAN THROUGH THE GASTROSTOMY TUBE AT 20ML PER HOUR. DAY 3: PT COMPLAINED OF BACK PAIN. DAY 4: PNEUMOPERITONEUM (AIR OR GAS IN THE PERITONEAL CAVITY) WAS NOTED. DAY 5: THE SURGEON EXAMINED THE PT WITH CT AND NOTED A PROBABLE SMALL AIR LEAK AROUND THE TUBE THAT WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. THE GASTROSTOMY TUBE WAS SECURED AND AUTHORIZATION WAS GIVEN TO CONTINUE FEEDING. DAY 6: PHYSICIAN WAS CALLED TO SEE THE PT FOR REPORT OF LEAKING CLEAR/YELLOWISH FLUID THAT WAS THOUGHT TO BE ASCITES FLUID. FEEDING WAS STOPPED. THE PATIENT'S ABDOMEN WAS DISTENDED ALTHOUGH NO RESIDUALS WERE NOTED. LATER IN THE DAY, A LARGE AMOUNT OF CLEAR YELLOW/GREEN FLUID WAS SEEN LEAKING AROUND THE GASTROSTOMY TUBE. THE PT WAS TAKEN TO THE OPERATING ROOM FOR EMERGENCY EXPLORATORY LAPAROTOMY. THE PT WAS FOUND TO HAVE PERITONITIS AND A DISLODGED PEG TUBE. THE INTERNAL BUMPER REMAINED INSIDE THE STOMACH. THE PT NOW HAD SEPSIS IN ADDITION TO UNDERLYING CIRRHOSIS, RESPIRATORY FAILURE AND SUBSEQUENT RENAL FAILURE. THE FAMILY WITHDREW CARE AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death