BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 15804301 · Received November 16, 2022

    Report

    Report Number
    1037905-2022-00638
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    March 24, 2022
    Report Date
    November 16, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CHA BH, PARK MJ, BAEG JY, ET AL. HOW OFTEN SHOULD PERCUTANEOUS GASTROSTOMY FEEDING TUBES BE REPLACED? A SINGLE-INSTITUTE RETROSPECTIVE STUDY. BMJ OPEN GASTRO 2022;9:E000881. DOI:10.1136/BMJGAST-2022-000881. 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: 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 IFU INDICATES THE FOLLOWING 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, GASTROCOLOCUTANEOUS OR SMALL BOWEL FISTULA, GASTRIC DILATATION, SIGMOID INTRA-ABDOMINAL HERNIATION AND VOLVUS, PERSISTENT FISTULA FOLLOWING PEG REMOVAL, ESOPHAGEAL INJURY, NECROTIZING FASCIITIS, CANDIDA CELLULITIS, IMPROPER PLACEMENT OR INABILITY TO PLACE PEG TUBE, TUBE DISLODGMENT OR MIGRATION, HEMORRHAGE, AND TUMOR METASTASIS.¿ THE IFU INCLUDES THE FOLLOWING WARNINGS: ¿EXCESSIVE TRACTION ON THE GASTRIC FEEDING TUBE MAY CAUSE PREMATURE REMOVAL, FATIGUE OR FAILURE OF THE DEVICE.¿ "WARNING: THE BOLSTER SHOULD SIT CLOSE TO THE SKIN BUT NOT TIGHT AGAINST THE SKIN." THE IFU STATES THE FOLLOWING: "USING THE ENCLOSED SCALPEL, MAKE A 1 CM LONG INCISION THROUGH THE SKIN, SUBCUTANEOUS TISSUE. CAUTION: A SMALLER INCISION MAY CONTRIBUTE TO EXTREME RESISTANCE OF THE GASTROSTOMY FEEDING TUBE WHEN EXITING THE FASCIA." THE IFU INDICATES THE FOLLOWING: ¿IMPORTANT: USE THE TWIST LOCK OR CABLE TIE TO SECURE THE BOLSTER TO THE TUBE. THIS WILL PREVENT FUTURE MIGRATION OF THE TUBE.¿ PRIOR TO DISTRIBUTION, ALL FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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. 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 · 0

    THE FOLLOWING WAS PUBLISHED IN A CLINICAL LITERATURE INVOLVING COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. RELEVANT EXCERPTS ARE AS FOLLOWS: ALTHOUGH THIS MINIMALLY INVASIVE PROCEDURE IS QUITE SAFE AND INSTRUCTIONS FOR TUBE CARE ARE WELL-KNOWN, THE RISKS OF MINOR OR MAJOR COMPLICATIONS (SUCH AS WOUND INFECTION, OCCLUSION, PERISTOMAL LEAKAGE, TUBE DISLODGEMENT, STOMAL HYPERGRANULATION, AND BURIED BUMPER SYNDROME) INCREASE AS LONG AS TUBE FEEDING PERSISTS. BECAUSE OF SUCH COMPLICATIONS, THE PG TUBE SHOULD BE EXCHANGED PERIODICALLY; THE STUDY POPULATION INCLUDED ALL PATIENTS WHO UNDERWENT ENDOSCOPIC OR RADIOLOGIC PG TUBE PLACEMENT (INITIAL OR EXCHANGE) FOR LONG-TERM ENTERAL FEEDING AT SHEIKH KHALIFA SPECIALTY HOSPITAL IN RAS AL KHAIMAH, UNITED ARAB EMIRATES, BETWEEN 2016 AND 2020. PG TUBE INSERTION WAS PERFORMED FOR PATIENTS DEEMED BY PHYSICIANS TO REQUIRE ENTERAL TUBE FEEDING FOR MORE THAN 30 DAYS IN ORDER TO AVOID ANY LONG-TERM COMPLICATIONS FROM NASOGASTRIC TUBE FEEDING. REPLACEMENT TUBES WERE INSERTED THROUGH THE STOMAL TRACT AFTER THE PREVIOUS TUBES WERE REMOVED; FOR THE INITIAL ENDOSCOPIC AND RADIOLOGIC PG TUBE INSERTION, WE USED A 20 FRENCH (FR) FLOW-20-PULL-I-S(COOK MEDICAL EUROPE) PG SET. COMPLICATIONS WERE: DISLOCATION OF THE TUBE: N (%) 9 (4.33) [SUBJECT OF THIS REPORT] ALL PATIENTS WHO UNDERWENT LONG-TERM ENTERAL FEEDING TUBE PLACEMENT AND REPLACEMENT PROCEDURES BY GASTROINTESTINAL ENDOSCOPISTS AND INTERVENTION RADIOLOGISTS AT SHEIKH KHALIFA SPECIALTY HOSPITAL BETWEEN 2015 AND 2020 WERE EXTRACTED FROM THE HOSPITAL¿S MEDICAL RECORDS SYSTEM. AMONG 721 TUBE PLACEMENTS, 599 WERE PG-RELATED AND REMNANT PROCEDURES, 62 INVOLVED NASOENTERIC FEEDING TUBE INSERTION, 4 WERE FOR FEEDING TUBES INSERTED VIA SURGICAL GASTROSTOMY OR JEJUNOSTOMY, AND 56 WERE FOR TUBE CHECK ONLY. IT WAS NOT REPORTED IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. IT WAS NOT PUBLISHED IF ANY ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. IT WAS NOT PUBLISHED IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355614 FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE - UNKNOWN MAKE AND MODEL