BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 14458872 · Received May 20, 2022

    Report

    Report Number
    1037905-2022-00233
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    October 19, 2013
    Report Date
    June 16, 2022
    Manufacturer
    WILSON COOK MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DOI: 10.1007/S10620-013-2891-7. 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. BLEEDING, PERITONITIS, NECROTIZING FASCIITIS, MIGRATION, AND INFECTION ARE KNOWN CLINICAL COMPLICATIONS. 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." THE IFU ALSO STATES, "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: PNEUMOPERITONEUM, PERISTOMAL WOUND INFECTION AND PURULENT DRAINAGE, STOMAL LEAKAGE, BOWEL OBSTRUCTION, GASTROESOPHAGEAL REFLUX (GERD), AND BLOCKAGE OR DETERIORATION OF THE PEG TUBE." 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

    THIS ARTICLE IS UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SENT. DOI: 10.1007/S10620-013-2891-7

    Additional Manufacturer Narrative · 0

    THIS ARTICLE REMAINS UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SENT. DOI: 10.1007/S10620-013-2891-7.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ORIGINALLY REPORTED: "COOK BECAME AWARE OF A CLINICAL LITERATURE ARTICLE INVOLVING COOK PEG-24-PULL-S DEVICES IN KOREA FROM DECEMBER 2002- DECEMBER 2012. THE FOLLOWING ARE RELEVANT EXCERPTS: "PEG TUBE PLACEMENT HAS BEEN PROVEN TO BE A SAFE, EFFECTIVE PROCEDURE BUT SOMETIMES COMPLICATIONS CAN OCCUR... RETROSPECTIVE REVIEW WAS PERFORMED TO IDENTIFY THE RECORDS OF PATIENTS REFERRED FOR PEG OR TUBE REPLACEMENT AT HANYANG UNIVERSITY HOSPITAL (SEOUL, KOREA) DURING THE 10-YEAR PERIOD BETWEEN DECEMBER 2002 TO DECEMBER 2012 (250 PATIENTS, 368 CASES)... MINOR COMPLICATIONS WERE PERISTOMAL INFECTION (FOR CASES WHERE THE EXISTING PEG WAS NOT REMOVED OR EXCHANGED) AND MINOR BLEEDING OR INJURY (ORAL CAVITY, GI TRACT, SKIN WOUND) [SUBJECT OF THIS REPORT]... [MINOR] COMPLICATIONS WERE OBSERVED IN 27 [PATIENTS]. TABLE 1 OUTLINES THE FOLLOWING DATA: MINOR COMPLICATIONS- 27, WHICH INCLUDE: ESOPHAGEAL INJURY WITH MINOR BLEEDING- 22, MINOR PERISTOMAL INFECTION- 4, HUGE BEZOAR- 1." NOTE: THIS ARTICLE IS UNDER INVESTIGATION. SEPARATE REPORTS MAY BE SENT TO CAPTURE DIFFERENT SEVERITIES UPON COMPLETION OF THE INVESTIGATION." THE SUBJECT OF THIS REPORT IS NOW THE FOLLOWING: INTRAMURAL HEMATOMA OF ESOPHAGUS- 1 PATIENT PERITONITIS- 3 PATIENTS. NECROTIZING FASCIITIS- 3 PATIENTS. BURIED BUMPER SYNDROME- 7 PATIENTS. PERISTOMAL INFECTION REQUIRING TUBE REMOVAL- 3 PATIENTS. MINOR PERISTOMAL INFECTION- 4 PATIENTS. THE IMPLANTED PEG REMAINED IN THE PATIENT'S BODY AS INTENDED. THE ADVERSE EFFECTS AND ADDITIONAL PROCEDURES PUBLISHED IN THE ARTICLE ARE OUTLINED IN THE DESCRIPTION OF EVENT.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF A CLINICAL LITERATURE ARTICLE INVOLVING COOK PEG-24-PULL-S DEVICES IN KOREA FROM DECEMBER 2002- DECEMBER 2012. THE FOLLOWING ARE RELEVANT EXCERPTS: "PEG TUBE PLACEMENT HAS BEEN PROVEN TO BE A SAFE, EFFECTIVE PROCEDURE BUT SOMETIMES COMPLICATIONS CAN OCCUR... RETROSPECTIVE REVIEW WAS PERFORMED TO IDENTIFY THE RECORDS OF PATIENTS REFERRED FOR PEG OR TUBE REPLACEMENT AT HANYANG UNIVERSITY HOSPITAL (SEOUL, KOREA) DURING THE 10-YEAR PERIOD BETWEEN DECEMBER 2002 TO DECEMBER 2012 (250 PATIENTS, 368 CASES)... MINOR COMPLICATIONS WERE PERISTOMAL INFECTION (FOR CASES WHERE THE EXISTING PEG WAS NOT REMOVED OR EXCHANGED) AND MINOR BLEEDING OR INJURY (ORAL CAVITY, GI TRACT, SKIN WOUND) [SUBJECT OF THIS REPORT]... [MINOR] COMPLICATIONS WERE OBSERVED IN 27 [PATIENTS]. TABLE 1 OUTLINES THE FOLLOWING DATA: MINOR COMPLICATIONS- 27, WHICH INCLUDE: ESOPHAGEAL INJURY WITH MINOR BLEEDING- 22 MINOR PERISTOMAL INFECTION- 4 HUGE BEZOAR- 1" THIS ARTICLE IS UNDER INVESTIGATION. SEPARATE REPORTS MAY BE SENT TO CAPTURE DIFFERENT SEVERITIES UPON COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200035 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