BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 14662879 · Received June 11, 2022

    Report

    Report Number
    1037905-2022-00284
    Event Type
    Injury
    Date Received
    June 11, 2022
    Date of Event
    November 1, 2021
    Report Date
    July 7, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT. NOTE: THIS REPORT WILL CAPTURE THE RESPIRATORY ARREST EVENT THAT WAS PREVIOUSLY REPORTED ON 05/19/2022 UNDER 1037905-2022-00226. LITERATURE REVIEW - NUTRITIONAL IMPACT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY: A RETROSPECTIVE SINGLE-CENTER STUDY KOREAN J GASTROENTEROL VOL. 79 NO. 1, 12-21 HTTPS://DOI.ORG/10.4166/KJG.2021.086 PISSN 1598-9992 EISSN 2233-6869.

    Additional Manufacturer Narrative · 0

    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. RESPIRATORY DISTRESS IS A KNOWN CLINICAL COMPLICATION. THERE IS NO EVIDENCE TO SUGGEST THE REPORT IS DUE TO A DEVICE FAILURE. THE IFU STATES 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 BOWL FISTULA, GASTRIC DILATION, SIGMOID INTRA-ABDOMINAL HERNIATION AND VOLVULUS, PERSISTENT FISTULA FOLLOWING PEG REMOVAL, ESOPHAGEAL INJURY, NECROTIZING FASCIITIS, CANDIDA CELLULITIS, IMPROPER PLACEMENT OF INABILITY TO PLACE PEG TUBE, TUBE DISLODGEMENT OR MIGRATION, HEMORRHAGE, AND TUMOR METASTASIS.". PRIOR TO DISTRIBUTION, ALL PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: 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. NOTE: THIS REPORT WILL CAPTURE THE RESPIRATORY ARREST EVENT THAT WAS PREVIOUSLY REPORTED ON 05/19/2022 UNDER 1037905-2022-00226. LITERATURE REVIEW - NUTRITIONAL IMPACT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY: A RETROSPECTIVE SINGLE-CENTER STUDY. KOREAN J GASTROENTEROL VOL. 79 NO. 1, 12-21. HTTPS://DOI.ORG/10.4166/KJG.2021.086. PISSN (B)(6). EISSN (B)(6).

    Description of Event or Problem · 0

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT VIA A CLINICAL LITERATURE ARTICLE AND INVOLVES THE USE OF A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL (PEG-24-PULL-S). THIS ARTICLE WAS PUBLISHED IN 2022. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. "THIS RETROSPECTIVE STUDY INCLUDED PATIENTS WHO UNDERWENT PEG AT THE CHUNGNAM NATIONAL UNIVERSITY HOSPITAL IN KOREA BETWEEN JANUARY 2013 AND DECEMBER 2018. A GASTROENTEROLOGIST PERFORMED ALL PEG PROCEDURES USING THE PULL TECHNIQUE, AND ALL PATIENTS WERE FOLLOWED UP FOR >3 WEEKS POSTOPERATIVELY.... COMPLICATIONS AND MORTALITY.....TABLE 6 LISTS THE COMPLICATIONS THAT OCCURRED WITHIN 2 DAYS AFTER PEG TUBE INSERTION. TEN OUT OF THE 151 PATIENTS WHO WERE ENROLLED EXPERIENCED THE FOLLOWING COMPLICATIONS AFTER PEG TUBE INSERTION: POSTOPERATIVE PNEUMOPERITONEUM (FOUR PATIENTS), [SUBJECT OF RELATED EMDR 1037905-2022-00226] ASPIRATION PNEUMONIA (FOUR PATIENTS), [SUBJECT OF RELATED EMDR 1037905-2022-00226] POSTOPERATIVE PANCREATITIS WITH PERITONITIS (ONE PATIENT), [SUBJECT OF RELATED EMDR 1037905-2022-00226] SURGICAL SITE INFECTION (ONE PATIENT), [SUBJECT OF RELATED EMDR 1037905-2022-00226] AND RESPIRATORY ARREST (ONE PATIENT) [SUBJECT OF THIS REPORT] ONE PATIENT EXPERIENCED BOTH ASPIRATION PNEUMONIA AND PNEUMOPERITONEUM [SUBJECT OF RELATED EMDR 1037905-2022-00226]. ALL PATIENTS RECOVERED WITHOUT SURGICAL INTERVENTION. OVERALL, 10 PATIENTS EXPERIENCED SHORT-TERM COMPLICATIONS RELATED TO PEG TUBE INSERTION IN THIS STUDY. ON THE OTHER HAND, NONE OF THESE COMPLICATIONS WERE FATAL AND THE PATIENTS RECOVERED WITHOUT SURGICAL INTERVENTION." IT IS ASSUMED THAT INTERVENTION WAS PERFORMED FOR THE PUBLISHED COMPLICATIONS, BUT SPECIFICS WERE NOT PUBLISHED IN THE ARTICLE. THE RELATED EMDR 1037905-2022-00226 WAS SUBMITTED AND CAPTURED ALL OF THE ABOVE LISTED ADVERSE EVENTS. UPON INVESTIGATION, IT WAS DETERMINED THAT A SEPARATE EMDR (THIS REPORT) WAS NEEDED TO CAPTURE THE RESPIRATORY ARREST EXPERIENCED BY ONE PATIENT. THE RELATED EMDR FOLLOW UP WILL BE SENT WITH THIS UPDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18857 PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention