BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 14788230 · Received June 23, 2022

    Report

    Report Number
    1037905-2022-00313
    Event Type
    Injury
    Date Received
    June 23, 2022
    Report Date
    July 20, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HTTPS://DOI.ORG/10.1177/2050640616662160. THIS ARTICLE IS UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    HTTPS://DOI.ORG/10.1177/2050640616662160. 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 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 PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL ARE SUBJECTED TO A VISUAL 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

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT INVOLVING PEG-24-PULL-S 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. EARLY TUBE REMOVAL (2), SUBJECT OF THIS REPORT. EARLY TUBE WITHDRAWAL HAPPENED TWO AND THREE DAYS AFTER PEG IN PATIENTS IN THE PULL TECHNIQUE GROUP. BOTH PATIENTS WERE STABLE, WITHOUT SIGNS OF PERITONITIS AND SEPSIS. WE TRIED TO PASS A GUIDEWIRE TO THE STOMACH THROUGH THE GASTROSTOMY INCISION WITHOUT SUCCESS, SO WE DECIDED TO PERFORM A TRANSGASTRIC EXPLORATION AND PEG RESCUE. BOTH PROCEDURES WERE SUCCESSFUL AND THE PATIENTS RECOVERED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331831 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