BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNT TUBES, GASTROINTESTINAL

    MDR report key: 8126049 · Received December 3, 2018

    Report

    Report Number
    1820334-2018-03551
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    June 7, 2015
    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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURE 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. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE INSTRUCTIONS FOR USE STATES THAT, "THE TDCS-100 IS RECOMMENDED FOR TRACT LENGTHS UP TO 6M. THE TDCS-100-M IS RECOMMENDED FOR TRACT LENGTHS FROM 3-9 CM. THE TDCS-100-L IS RECOMMENDED FOR TRACT LENGTHS FROM 6-14 CM. PRE-PLACEMENT RECOMMENDATIONS: USE OF SUTURE ANCHORS IS RECOMMENDED TO ASSIST INTRODUCTION OF THE TEMPORARY DRAINAGE CATHETER. INSTRUCTIONS FOR USE: 2. CAREFULLY PULL CATHETER OUT OVER PRE-POSITIONED WIRE GUIDE. DETERMINE CECOSTOMY TRACT LENGTH AND PLACE APPROPRIATELY SIZED CATHETER. NOTE: CONFIRM THAT TRACT IS APPROPRIATE LENGTH TO ACCOMMODATE CHAIT TRAPDOOR CECOSTOMY CATHETER BY ADVANCING WIRE GUIDE, UNDER FLUOROSCOPY, UNTIL TIP IS WITHIN CECUM AND MEASURE DISTANCE FROM HEMOSTAT TO WIRE GUIDE TIP. 4. PERFORM CONTRAST INJECTION TO CONFIRM CATHETER POSITION AND PATENCY WITHIN CECUM. TO MEASURE THE TRACT LENGTH USING A WIRE GUIDE AND FLUOROSCOPIC IMAGING." BASED ON THE INVESTIGATION AND AVAILABLE INFORMATION IT IS LIKELY THAT THE DESCRIBED EVENT CAN BE ATTRIBUTED TO USING THE INCORRECT CATHETER AS A RESULT OF USING BODY MASS INDEX TO ESTIMATE TRACT LENGTH. THE SOURCE ARTICLE STATES THAT THE SIZE OF THE CATHETERS USED DURING THE PROCEDURE WAS DETERMINED BASED ON THE BODY MASS INDEX OF THE PATIENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND NOTIFY APPROPRIATE PERSONNEL 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.

    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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. DEVICE NAME: CHAIT PERCUTANEOUS CECOSTOMY CATHETER. (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 REPORT OF COMPLICATIONS EXPERIENCED DURING A PERCUTANEOUS CECOSTOMY STUDY WAS DETAILED IN THE FOLLOWING ARTICLE: DAVID MARKER, NICOLAS PEROSI, FAHEEM HAQ, ET AL. "PERCUTANEOUS CECOSTOMY IN ADULT PATIENTS: SAFETY AD QUALITY-OF-LIFE RESULTS." J VAS INTERV RADIOL 26 (2015): 1526-1532. THIS ARTICLE DETAILS A CLINICAL STUDY CONSISTING OF 23 PATIENTS WHO RECEIVED A PERCUTANEOUS CECOSTOMY FOR THE TREATMENT AND MANAGEMENT OF SEVERE CONSTIPATION LEADING TO FECAL INCONTINENCE. AFTER BOWEL PREPARATION WITH MEDICATION AND RECTAL TUBES (IF NECESSARY), 8.5FR DAWSON-MUELLER MAC-LOC 15 CM CATHETERS WERE PLACED IN THE CECUM. POSITIONING WAS CONFIRMED WITH CONTRAST MATERIAL. AFTER 10 DAYS, THE SUTURES FROM THE INITIAL PROCEDURE WERE REMOVED AND PATIENTS RECEIVED INSTRUCTIONS FOR EVACUATION ENEMAS. AFTER 6 WEEKS, THE CATHETER WAS EXCHANGED FOR A 10.2FR CHAIT TRAPDOOR CATHETER. THE CHAIT CATHETER WAS EXCHANGED EVERY YEAR OR AS COMPLICATIONS AROSE. CONTRAST MATERIAL CONFIRMED THE POSITIONING OF THE CHAIT CATHETERS. ALL 23 PRIMARY CECOSTOMY PROCEDURES WERE TECHNICALLY SUCCESSFUL. COMPLICATIONS AT FOLLOW-UP RELATED TO THE CHAIT TUBE INCLUDED LEAKING AND COMPLETE OR PARTIAL DEVICE DISLODGEMENT. FIVE PATIENTS EXPERIENCED LEAKING AROUND THE TUBE. TWO OF THESE PATIENTS HAD MODERATE GRANULATION TISSUE AT THE SKIN SITE AND UNDERWENT CAUTERIZATION USING SILVER NITRATE. THREE PATIENTS WHO EXPERIENCED RECURRENT LEAKING HAD TUBE UPSIZES FOR BALLOON OCCLUSION OF THE TRACT. THESE LEAKAGE COMPLICATIONS ARE RECORDED UNDER MEDWATCH REPORT #1820334-2018-03541. THREE PATIENTS EXPERIENCED PARTIAL OR COMPLETE CHAIT TUBE DISLODGEMENT. THESE PATIENTS ARE RECORDED UNDER THIS MEDWATCH REPORT. IN ALL CASES, THE CECOSTOMY TUBE WAS SUCCESSFULLY EXCHANGED. OTHER COMPLICATIONS THAT OCCURRED INCLUDED PAIN AT THE SITE FOR TWO PATIENTS, A FEVER FOR ONE PATIENT, AND MULTIPLE COMPLICATIONS FOR ONE PATIENT ATTRIBUTED TO NONCOMPLIANCE. THE NONCOMPLIANCE RELATED COMPLICATIONS INCLUDED FEVER, HIGH WHITE BLOOD CELL COUNT, CHILLS, PAIN, T-TACK SEPARATION, AND ABSCESS FORMATION. NONE OF THESE COMPLICATIONS WERE INDICATED TO BE RELATED TO THE CHAIT CATHETER. ALL OF THE COMPLICATIONS WERE RESOLVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966937 KNT TUBES, GASTROINTESTINAL KNT COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention