CHAIT PERCUTANEOUS CECOSTOMY CATHETER
Report
- Report Number
- 1820334-2025-00689
- Event Type
- Injury
- Date Received
- June 10, 2025
- Date of Event
- September 2, 2020
- Report Date
- January 26, 2026
- Manufacturer
- COOK INC
- Product Code
- KNT
- PMA / PMN Number
- K982500
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTION: H6 - ANNEX A. INVESTIGATION EVALUATION: IT WAS REPORTED THAT A CHAIT PERCUTANEOUS CECOSTOMY CATHETER DISLODGED. THE CHAIT DEVICE WAS PLACED ON (B)(6) 2020 DURING AN INITIAL CECOSTOMY CATHETER PLACEMENT PROCEDURE. NO TEMPORARY CATHETER WAS PLACED PRIOR TO PLACEMENT OF THE CHAIT. THE DEVICE WAS PLACED RELATED TO SEVERE CHRONIC CONSTIPATION AND NON-RELAXING INTERNAL SPHINCTERS. DURING THE PROCEDURE, FLUOROSCOPY IMAGE GUIDANCE WAS USED TO PLACE THE CATHETER LAPAROSCOPICALLY IN THE CECUM. THE PROCEDURE AND INITIAL BOWEL EVACUATION WERE SUCCESSFUL. NO DEVICE DEFICIENCIES OR ADVERSE EVENTS WERE IDENTIFIED DURING THE PROCEDURE. PHOSPHATE ENEMA AND WATER WERE INSTILLED THROUGHOUT THE DURATION THE CHAIT REMAINED IN PLACE. ON (B)(6) 2020 (38 DAYS POST-PROCEDURE), A 30-DAY FOLLOW-UP ASSESSMENT WAS PERFORMED. IT WAS NOTED THAT THE PATIENT EXPERIENCED AN IMPROVEMENT OF SYMPTOMS. ON (B)(6) 2020 (180 DAYS POST-PROCEDURE), CATHETER DISPLACEMENT WAS SUSPECTED DUE TO CONCERN OF PERSISTENT ABDOMINAL TENDERNESS. FLUOROSCOPY FINDINGS SUGGEST THAT PARTS OF TUBE COIL MAY BE PARTIALLY OUTSIDE OF THE LUMEN OF THE CECUM. NO LEAKAGE WAS NOTED. AS A RESULT, THE CATHETER WAS SUCCESSFULLY REMOVED AND REPLACED. NO OTHER ADVERSE EVENTS WERE REPORTED. REVIEWS OF DOCUMENTATION INCLUDING QUALITY CONTROL AND INSTRUCTIONS FOR USE (IFU) FOR THE DEVICE WERE 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. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH TO THE CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: ¿CONTRAINDICATIONS ¿ PREVIOUS ABDOMINAL SURGICAL PROCEDURES. PRECAUTIONS. ¿ INSTRUCT PATIENT TO READ AND UNDERSTAND THE PATIENT GUIDE TITLED ¿CARING FOR YOUR TEMPORARY & CHAIT TRAPDOOR CECOSTOMY CATHETERS¿ PRIOR TO INITIAL CATHETER INTRODUCTION. ¿THE CATHETER SHOULD BE CHANGED EVERY 6 MONTHS TO REDUCE THE RISK OF CATHETER FRACTURE IN THE PATIENT. ¿ FOR TRACT LENGTHS BETWEEN 6 AND 14 CM, SEE SIZING RECOMMENDATIONS FOR APPROPRIATE SIZE. IF CECOSTOMY TRACT IS GREATER THAN 14 CM, A MULTIPURPOSE DRAINAGE CATHETER SHOULD BE USED. PRE-PLACEMENT RECOMMENDATIONS PLACEMENT OF THE CHAIT TRAPDOOR CECOSTOMY CATHETER IS A TWO-STEP PROCEDURE. INITIALLY, A TEMPORARY LOOP RETENTION DRAINAGE CATHETER IS PERCUTANEOUSLY PLACED INTO THE CECUM AND MAINTAINED WHILE THE TRACT MATURES. NOTE: AFTER APPROPRIATE TRACT MATURATION, THE TEMPORARY DRAINAGE CATHETER SHOULD BE REMOVED AND REPLACED WITH THE CHAIT TRAPDOOR CECOSTOMY CATHETER. (THIS WILL BE APPROXIMATELY 6 WEEKS AFTER INITIAL PROCEDURE).¿ BASED ON THE INFORMATION PROVIDED, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. IT WAS REPORTED THAT THE MIGRATION OCCURRED SIX MONTHS AFTER PLACEMENT. THE IFU RECOMMENDS THE DEVICE BE REPLACED AFTER SIX MONTHS. DEGRADATION OR WEAKENING OF THE PIGTAIL COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS ALSO POSSIBLE THAT ACCIDENTAL FORCE/TRACTION WAS EXERTED ON THE CATHETER DURING USE. HOWEVER, THESE POSSIBILITIES ARE UNABLE TO BE CONFIRMED WITHOUT ADDITIONAL INFORMATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: EXD IRRIGATOR, OSTOMY D2B - PROCODE: ADDITIONAL PRODUCT CODES: EXD. E3 - OCCUPATION: PRIMARY INVESTIGATOR. H3 - DEVICE EVALUATED BY MFG? DEVICE NOT RETURNED TO MANUFACTURER. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
ADDITIONAL INFORMATION: B5, CORRECTION: D4: LOT #, D4: EXPIRATION DATE, H4: DEVICE MFG DATE THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IT WAS REPORTED THAT A CHAIT PERCUTANEOUS CECOSTOMY CATHETER DISLODGED. THE CHAIT DEVICE WAS PLACED ON (B)(6) 2020 DURING AN INITIAL CECOSTOMY CATHETER PLACEMENT PROCEDURE. NO TEMPORARY CATHETER WAS PLACED PRIOR TO PLACEMENT OF THE CHAIT. THE DEVICE WAS PLACED RELATED TO SEVERE CHRONIC CONSTIPATION AND NON-RELAXING INTERNAL SPHINCTERS. DURING THE PROCEDURE, FLUOROSCOPY IMAGE GUIDANCE WAS USED TO PLACE THE CATHETER LAPAROSCOPICALLY IN THE CECUM. THE PROCEDURE AND INITIAL BOWEL EVACUATION WERE SUCCESSFUL. NO DEVICE DEFICIENCIES OR ADVERSE EVENTS WERE IDENTIFIED DURING THE PROCEDURE. PHOSPHATE ENEMA AND WATER WERE INSTILLED THROUGHOUT THE DURATION THE CHAIT REMAINED IN PLACE. ON (B)(6) 2020 (38 DAYS POST-PROCEDURE), A 30-DAY FOLLOW-UP ASSESSMENT WAS PERFORMED. IT WAS NOTED THAT THE PATIENT EXPERIENCED AN IMPROVEMENT OF SYMPTOMS. ON (B)(6) 2020 (180 DAYS POST-PROCEDURE), CATHETER DISPLACEMENT WAS SUSPECTED DUE TO CONCERN OF PERSISTENT ABDOMINAL TENDERNESS. NO LEAKAGE WAS NOTED. AS A RESULT, THE CATHETER WAS SUCCESSFULLY REMOVED AND REPLACED. NO OTHER ADVERSE EVENTS WERE REPORTED.
IN ADDITIONAL INFORMATION RECEIVED ON 02JUL2025, IT WAS REPORTED THAT FLUOROSCOPY FINDINGS SUGGEST THAT PARTS OF TUBE COIL MAY BE PARTIALLY OUTSIDE OF THE LUMEN OF THE CECUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2200580 | CHAIT PERCUTANEOUS CECOSTOMY CATHETER | KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | COOK INC | G12685 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Female | Required Intervention |