BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH

    MDR report key: 3049485 · Received April 4, 2013

    Report

    Report Number
    1037905-2013-00132
    Event Type
    Death
    Date Received
    April 4, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 7, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION 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. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING: CONTRAINDICATIONS. CONTRAINDICATIONS ASSOCIATED WITH PLACEMENT AND USE OF A PEG TUBE INCLUDE, BUT ARE NOT LIMITED TO: SEPSIS, SEVERE GASTROESOPHAGEAL REFLUX, ASCITES, OR DIFFUSE INFLAMMATORY, INFECTIOUS, OR NEOPLASTIC DISEASE INVOLVING THE WALLS OF THE ABDOMEN OR ANTERIOR STOMACH, GASTROINTESTINAL OBSTRUCTION OR PROXIMAL SMALL BOWEL FISTULAE. POTENTIAL COMPLICATIONS: POTENTIAL COMPLICATIONS ASSOCIATED WITH PLACEMENT AND USE OF A PEG TUBE INCLUDE, BUT ARE NOT LIMITED TO: BRONCHOPULMONARY ASPIRATION AND PNEUMONIA, RESPIRATORY DISTRESS OR AIRWAY OBSTRUCTION, PERITONITIS OR SEPTIC SHOCK, COLOCUTANEOUS, GASTROCOLOTANEOUS OR SMALL BOWEL FISTULAS, GASTRIC DILATION, SIGMOID INTRA-ABDOMINAL HERNIATION AND VOLVUS, ESOPHAGEAL INJURY, NECROTIZING FASCITIS, CANDIDA CELLULITIS, IMPROPER PLACEMENT OR INABILITY TO PLACE PEG TUBE, TUBE DISLODGEMENT OR MIGRATION. WARNING: EXCESSIVE TRACTION ON THE GASTRIC FEEDING TUBE MAY CAUSE PREMATURE REMOVAL, FATIGUE OR FAILURE OF THE DEVICE. PRECAUTIONS: THE BENEFIT OF A PEG TUBE TO PATIENT MUST BE WEIGHED AGAINST THE RISKS ASSOCIATED WITH ANY INDWELLING GASTROSTOMY FEEDING TUBE. A THOROUGH UNDERSTANDING OF THE TECHNICAL PRINCIPLES, CLINICAL APPLICATIONS AND RISKS ASSOCIATED WITH PLACEMENT AND/OR REMOVAL OF A PEG TUBE IS NECESSARY BEFORE USING THE DEVICE. PLACEMENT OF THE PEG TUBE SHOULD ONLY BE PERFORMED BY, OR UNDER SUPERVISION OF, PHYSICIANS THOROUGHLY TRAINED IN THE PROCEDURE. DURING PLACEMENT AND USE, CARE MUST BE TAKEN TO AVOID CUTTING, CRIMPING, OR "DAMAGING COMPONENTS." IF THE PRODUCT PACKAGE IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE THIS DEVICE: VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS AND BREAKS IN THE FEEDING TUBE ASSEMBLY. THE INSTRUCTIONS FOR USE PROVIDE THE CUSTOMER WITH INFORMATION ON HOW TO PROPERLY PLACE THE FEEDING TUBE. PRIOR TO DISTRIBUTION, ALL ENTERAL FEEDING PRODUCTS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT HAD A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET PLACED. ON THE MORNING OF (B)(6) 2013, PATIENT DEVELOPED ABDOMINAL DISTENTION, TACHYCARDIA AND TACHYPNEA. CHEST X-RAY SHOWED 'NEW MODERATE TO LARGE VOLUME FREE INTRA-ABDOMINAL AIR". ATTENDING PHYSICIAN DOCUMENTED "POSSIBLE BOWEL PERFORATION, PEG DISPLACEMENT?" FAMILY REQUESTED COMFORT CARE ONLY AND PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139344 FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC W3228875

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death REQUESTED BUT NOT PROVIDED