BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 14455740 · Received May 20, 2022

    Report

    Report Number
    1037905-2022-00230
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    February 1, 2015
    Report Date
    July 12, 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

    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 - THE USEFULNESS AND SAFETY OF THE INTRODUCER TECHNIQUE USING A BUMPER-BUTTON¿TYPE DEVICE AS COMPARED WITH THE PULL METHOD FOR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TETSURO OHNO, MD, PHD (SURG LAPAROSC ENDOSC PERCUTAN TECH 2015;25:E1¿E4).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    LITERATURE REVIEW - THE USEFULNESS AND SAFETY OF THE INTRODUCER TECHNIQUE USING A BUMPER-BUTTON¿TYPE DEVICE AS COMPARED WITH THE PULL METHOD FOR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY. TETSURO OHNO, MD, PHD (SURG LAPAROSC ENDOSC PERCUTAN TECH 2015;25:E1¿E4). 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, ASPIRATION PNEUMONIA, PERITONITIS, 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.

    Description of Event or Problem · 0

    COOK ENDOSCOPY WAS NOTIFIED OF ADVERSE EVENTS INVOLVING COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL (PEG-24-PULL-S) VIA A CLINICAL LITERATURE ARTICLE. THIS ARTICLE WAS PUBLISHED IN 2015. BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. THE PULL PEG PROCEDURE WAS PERFORMED... USING THE PEG-24 KIT (WILSON-COOK MEDICAL INC., NC)... ON 22 PATIENTS WHO HAD PROCEDURES USING THE PULL TECHNIQUE FROM MAY 2007 TO OCTOBER 2008... THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS FROM TABLE 3 INCLUDE POSTOPERATIVE BLEEDING (1), ASPIRATION PNEUMONIA (1), POSTOPERATIVE PERITONITIS (1), PERISTOMAL INFECTION (4). NOTE: THESE EVENTS ARE 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
    2449722 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