BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNT TUBES, GASTROINTESTINAL

    MDR report key: 8120789 · Received November 30, 2018

    Report

    Report Number
    1820334-2018-03543
    Event Type
    Injury
    Date Received
    November 30, 2018
    Date of Event
    January 22, 2014
    Report Date
    March 1, 2019
    Manufacturer
    COOK INC
    Product Code
    KNT
    PMA / PMN Number
    K982500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI) AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. ON PAGE 1424, OF THE SOURCE ARTICLE ENTITLED SURGICAL TECHNIQUE, THE AUTHOR RELATES THAT SUTURE ANCHORS WERE USED TO SECURE THE CECUM DURING INITIAL CATHETER PLACEMENT. THE METHODOLOGY FOR CHOOSING THE SIZE OF THE CHAIT TUBE WAS NOT MENTIONED. IT WAS ALSO STATED THAT THE DISLODGEMENTS OCCURRED "MOSTLY WHILE THEY WERE BECOMING FAMILIAR WITH THE USE OF THE CHAIT TUBE". IT IS POSSIBLE TO ATTRIBUTE TO USER PLACEMENT ERROR, OR MAINTENANCE OF THE DEVICE. A REVIEW OF THE INSTRUCTIONS FOR USE(IFU) INCLUDED WITH THE PRODUCT LIST THE RECOMMENDED TUBE SIZE BASED ON THE TRACT LENGTH OF THE PATIENT. IT INSTRUCTS THE PHYSICIAN TO MEASURE THE TRACT LENGTH BEFORE PLACEMENT OF THE LONG TERM CHAIT CATHETER BY INTRODUCING A WIRE GUIDE UNDER FLUOROSCOPIC GUIDANCE AND MEASURING THE TRACT LENGTH BY MEASURING THE WIRE GUIDE. IT ALSO INSTRUCTS TO ENSURE THE CORRECT POSITIONING OF THE LONG TERM CATHETER WITH FLUOROSCOPY AFTER PLACEMENT. AS A RESULT OF THE INVESTIGATION AND A REVIEW OF THE AVAILABLE INFORMATION THE ROOT CAUSE OF THIS EVENT IS LIKELY TO BE TRACED TO THE USER. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. - ATTACHMENT: [MYERS_SHORT-TERM OUTCOMES OF CHAIT TRAPDOOR.PDF].

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PRODUCT IDENTIFIER: SPECIFIC PRODUCT INFORMATION UNKNOWN. CONCOMITANT PRODUCTS: 10.2FR DAWSON MUELLER DRAINAGE CATHETERS (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE BELOW DESCRIPTION OF PATIENTS DEVELOPING ABSCESSES WAS DESCRIBED IN THE FOLLOWING ARTICLE: JEREMY MYERS, ERIC HU, SEAN ELLIOT, ET AL. "SHORT-TERM OUTCOMES OF CHAIT TRAPDOOR FOR ANTEGRADE CONTINENCE ENEMA IN ADULTS." UROLOGY 83.6 (2014): 1423-1426. IT WAS STATED IN THE ARTICLE THAT 10.2FR DAWSON MUELLER DRAINAGE CATHETERS WERE USED TO ACCESS THE COLON IN 15 PATIENTS WITH INTRACTABLE NEUROGENIC BOWEL. A CHAIT TRAPDOOR WAS THEN PLACED 1-2 MONTHS AFTER THE INITIAL CATHETER PLACEMENT TO DELIVER ANTEGRADE CONTINENCE ENEMA (ACE). IN TWO PATIENTS, SUBCUTANEOUS ABSCESSES DEVELOPED APPROXIMATELY 2 WEEKS AFTER PLACEMENT OF THE DAWSON MUELLER CATHETER. THESE PATIENTS REQUIRED OPEN DRAINAGE AND ARE RECORDED UNDER MEDWATCH REPORT #1820334-2018-03542. FIVE PATIENTS EXPERIENCED CHAIT DISLODGEMENT REQUIRING REPLACEMENT BY INTERVENTIONAL RADIOLOGY. NO OTHER ADVERSE EFFECTS ARE STATED FOR THESE PATIENTS. THESE PATIENTS ARE RECORDED UNDER THIS MEDWATCH REPORT. OTHER COMPLICATIONS INCLUDED TWO PATIENTS DEVELOPING LOCALIZED CELLULITIS AROUND THE CHAIT SITE AND TWO PATIENTS REQUIRING THE CHAIT BEING MOVED TO A NEW LOCATION. THESE COMPLICATIONS WERE CONSIDERED TO BE MINOR AND THERE IS NO INDICATION THEY ARE RELATED TO THE CHAIT DEVICE. NO FURTHER ADDITIONAL PROCEDURES OR COMPLICATIONS FOR THESE PATIENTS WERE DESCRIBED IN THE LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959590 KNT TUBES, GASTROINTESTINAL KNT COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention