BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 4187708 · Received October 2, 2014

    Report

    Report Number
    1037905-2014-00383
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 16, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LAB EVAL OF THE PRODUCT CONFIRMED THE REPORT OF THE LOOPED WIRE SEPARATING FROM THE FEEDING TUBE. THE FEEDING TUBE WAS RETURNED WITH THE LOOP WIRE DETACHED AND THE SECURING COMPONENT FOR THE LOOP WIRE REMAINING INSIDE THE CONNECTOR OF THE FEEDING TUBE. THE PULL WIRE AND LOOP WIRE WERE NOT INCLUDED WITH THE RETURNED PRODUCT FOR INVESTIGATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED 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 COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. FEEDING TUBE SEPARATION CAN OCCUR IF THE INCISION THROUGH THE SKIN IS LESS THAN 1CM IN LENGTH OR DOES NOT COMPLETELY PENETRATE THE ABDOMINAL WALL INTO THE STOMACH. THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO MAKE A 1CM INCISION THROUGH THE SKIN AND SUBCUTANEOUS TISSUE TO FACILITATE PASSAGE OF THE FEEDING TUBE. A SMALLER OR INCOMPLETE INCISION MAY CAUSE ASSISTANCE WHEN THE FEEDING TUBE EXITS THE STOMA SITE. IF THE TUBE EXPERIENCE EXCESSIVE PRESSURE DURING PLACEMENT, DAMAGE TO THE FEEDING TUBE CAN OCCUR. INADEQUATE LUBRICATION OF THE FEEDING TUBE PRIOR TO PLACEMENT COULD CONTRIBUTE TO EXCESSIVE PRESSURE AND SUBSEQUENT FEEDING TUBE DAMAGED. THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO THOROUGHLY LUBRICATE THE ENTIRE EXTERNAL LENGTH OF THE FEEDING TUBE. THIS ACTIVITY WILL AID IN SMOOTH FEEDING TUBE PLACEMENT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY GENTLE PRESSURE TO THE FEEDING TUBE DURING PLACEMENT. PRIOR TO DISTRIBUTION, ALL PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE FOLLOWING INFO WAS PROVIDED. DURING THE PROCEDURE, A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL WAS USED. UPON PULLING THE TUBE THROUGH THE INCISION, THE WIRE LOOP BROKE. NO SECTION OF THE DEVICE DETACHED OR BECAME FREE INSIDE THE PT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. UPON EVAL OF THE RETURNED DEVICE, IT WAS DETERMINED THAT THE LOOP WIRE ATTACHED TO THE PEG TUBE (USED FOR PLACEMENT OF THE TUBE) WAS NOT INCLUDED WITH THE RETURNED DEVICE. ALTHOUGH THE INITIAL REPORT INDICATED THAT NO PORTION OF THE DEVICE REMAINED INSIDE THE PT, INFO REGARDING THE MISSING SECTION WAS COMMUNICATED BACK TO THE MEDICAL FACILITY. ON 09/25/2014, THE FOLLOWING ADD'L INFO WAS PROVIDED BY THE FDA, PER MAUDE EVENT REPORT RECEIVED, PT HAVING PZG [PEG] PROCEDURE DONE. ALL THE PORT OF THE MD PULLING THE PEG THROUGH THE ABDOMINAL INCISION, THE PEG TUBE WIRE [LOOP] BROKE. MD TRIED TO PULL THE TUBE THROUGH USING A STERILE HEMOSTAT, BUT SEVERAL ATTEMPTS WERE UNSUCCESSFUL. ANOTHER INCISION NEEDED TO BE MADE AND PEG PROCEDURE HAD TO BE REPEATED USING A NEW KIT. THERE WAS NO HARM TO PT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE DOCTOR TRIED TO PULL THE TUBE THROUGH USING STERILE HEMOSTASIS, BUT SEVERAL ATTEMPTS WERE UNSUCCESSFUL. ANOTHER INCISION WAS MADE AND THE PEG PROCEDURE HAD TO BE REPEATED USING A NEW KIT. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614066 FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC. W3413792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention