BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 14458497 · Received May 20, 2022

    Report

    Report Number
    1037905-2022-00231
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    December 1, 2008
    Report Date
    June 15, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE REVIEW: COMPARISON OF THE PULL AND INTRODUCER PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TECHNIQUES IN PATIENTS WITH HEAD AND NECK CANCER. UNITED EUROPEAN GASTROENTEROLOGY JOURNAL 2017, VOL. 5(3) 365¿373 AUTHOR(S) 2016 REPRINTS AND PERMISSIONS: SAGEPUB.CO.UK/JOURNALSPERMISSIONS.NAV DOI: 10.1177/2050640616662160 JOURNALS.SAGEPUB.COM/HOME/UEG. 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 FAILURE 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.

    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: THESE EVENTS ARE STILL UNDER REVIEW AND INVESTIGATION. SEPARATE REPORTS TO FURTHER CAPTURE THE DIFFERENT SEVERITIES OF COMPLICATIONS MAY BE SUBMITTED BASED ON THE OUTCOME OF THE INVESTIGATION. LITERATURE REVIEW: COMPARISON OF THE PULL AND INTRODUCER PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TECHNIQUES IN PATIENTS WITH HEAD AND NECK CANCER. UNITED EUROPEAN GASTROENTEROLOGY JOURNAL 2017, VOL. 5(3) 365¿373 AUTHOR(S) 2016 REPRINTS AND PERMISSIONS: SAGEPUB.CO.UK/JOURNALSPERMISSIONS.NAV DOI: 10.1177/2050640616662160 JOURNALS.SAGEPUB.COM/HOME/UEG.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ORIGINALLY REPORTED: "COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT INVOLVING COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL VIA A CLINICAL LITERATURE ARTICLE. THIS ARTICLE WAS PUBLISHED IN 2017. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. THIS STUDY WAS BASED ON A RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY COLLECTED DATABASE OF ALL PATIENTS WITH HNC (HEAD AND NECK CANCER) WHO UNDERWENT PEG AT THE CANCER INSTITUTE OF SAO PAULO FROM DECEMBER 2008 TO OCTOBER 2013. THE INDICATION FOR PEG PLACEMENT WAS MADE BY THE TREATING ONCOLOGIST OR HEAD AND NECK SURGEON.... THE FOLLOWING COMPLICATIONS OCCURRED..... RESPIRATORY FAILURE (2) BURIED BUMPER SYNDROME (6) PERITONITIS (1) UPPER GI BLEEDING (1), MINOR BLEEDING (1) ESOPHAGEAL LACERATION (2), MALLORY - WEISS SYNDROME (1), WOUND INFECTION (15), PERISTOMAL LEAKAGE (5), ABDOMINAL PAIN (7), GRANULATION TISSUE (7) AND DERMATITIS (3) MAJOR COMPLICATIONS WERE RESOLVED WITH ENDOSCOPY, SURGICAL INTERVENTION, OR PROLONGED INTERVENTION. MINOR COMPLICATIONS REQUIRED ONLY LOCAL AND CONSERVATIVE TREATMENT. NOTE: THESE EVENTS ARE STILL UNDER REVIEW AND INVESTIGATION. SEPARATE REPORTS TO FURTHER CAPTURE THE DIFFERENT SEVERITIES OF COMPLICATIONS MAY BE SUBMITTED BASED ON THE OUTCOME OF THE INVESTIGATION." THE SUBJECT OF THIS REPORT IS NOW "RESPIRATORY FAILURE (2 PATIENTS).... SURGICAL INTERVENTION WAS REQUIRED." THE OTHER PUBLISHED AES WILL BE CAPTURED IN SEPARATE EMDRS.

    Description of Event or Problem · 0

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT INVOLVING COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL VIA A CLINICAL LITERATURE ARTICLE. THIS ARTICLE WAS PUBLISHED IN 2017. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. THIS STUDY WAS BASED ON A RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY COLLECTED DATABASE OF ALL PATIENTS WITH HNC (HEAD AND NECK CANCER) WHO UNDERWENT PEG AT THE CANCER INSTITUTE OF SAO PAULO FROM DECEMBER 2008 TO OCTOBER 2013. THE INDICATION FOR PEG PLACEMENT WAS MADE BY THE TREATING ONCOLOGIST OR HEAD AND NECK SURGEON. THE FOLLOWING COMPLICATIONS OCCURRED: RESPIRATORY FAILURE (2), BURIED BUMPER SYNDROME (6), PERITONITIS (1), UPPER GI BLEEDING (1), MINOR BLEEDING (1), ESOPHAGEAL LACERATION (2), MALLORY - WEISS SYNDROME (1), WOUND INFECTION (15), PERISTOMAL LEAKAGE (5), ABDOMINAL PAIN (7), GRANULATION TISSUE (7) AND DERMATITIS (3). MAJOR COMPLICATIONS WERE RESOLVED WITH ENDOSCOPY, SURGICAL INTERVENTION, OR PROLONGED INTERVENTION. MINOR COMPLICATIONS REQUIRED ONLY LOCAL AND CONSERVATIVE TREATMENT. NOTE: THESE EVENTS ARE STILL UNDER REVIEW AND INVESTIGATION. SEPARATE REPORTS TO FURTHER CAPTURE THE DIFFERENT SEVERITIES OF COMPLICATIONS MAY BE SUBMITTED BASED ON THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368894 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| H