CHAIT PERCUTANEOUS CECOSTOMY CATHETER
Report
- Report Number
- 1820334-2025-00677
- Event Type
- Injury
- Date Received
- June 9, 2025
- Date of Event
- March 4, 2019
- Report Date
- November 20, 2025
- 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
INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT A CHAIT PERCUTANEOUS CECOSTOMY CATHETER DISLODGED. THE PATIENT'S FIRST CECOSTOMY CATHETER WAS PLACED ON (B)(6) 2017. THE CHAIT DEVICE WAS PLACED ON (B)(6) 2019 DURING A ROUTINE EXCHANGE PROCEDURE. THE DEVICE WAS PLACED RELATED TO CONSTIPATION, NEUROPATHIC BOWEL, PARAPLEGIA, AND SPINA BIFIDA. DURING THE PROCEDURE, FLUOROSCOPY IMAGE GUIDANCE WAS USED TO PLACE THE CATHETER PERCUTANEOUSLY IN THE CECUM. THE PROCEDURE AND INITIAL BOWEL EVACUATION WERE SUCCESSFUL. NO DEVICE DEFICIENCIES OR ADVERSE EVENTS WERE IDENTIFIED DURING THE PROCEDURE. WATER AND CASTILLE SOAP WERE INSTILLED THROUGHOUT THE DURATION THE CHAIT REMAINED IN PLACE. A 30-DAY POST PROCEDURE FOLLOW-UP ASSESSMENT WAS NOT PERFORMED. ON (B)(6) 2019 (40 DAYS POST-PROCEDURE), THE PATIENT WAS EMPTYING THEIR CECOSTOMY BAG AND DISCOVERED THE CATHETER HAD DISLODGED AND WAS UNABLE TO REDUCE IT. AS A RESULT, SURGICAL INTERVENTION WAS REQUIRED TO REMOVE AND REPLACE THE DEVICE THE FOLLOWING DAY ((B)(6) 2019). A FOLLOW-UP ASSESSMENT WAS PERFORMED ON (B)(6) 2019 (174 DAYS POST PROCEDURE); NO OTHER ADVERSE EVENTS WERE REPORTED. REVIEWS OF DOCUMENTATION INCLUDING QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE (IFU) OF THE COMPLAINT 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. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICE. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: ¿INTENDED USE THE CHAIT TRAPDOOR CECOSTOMY CATHETER IS INTENDED TO INSTILL FLUIDS THROUGH A CECOSTOMY INTO THE COLON TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER BOWEL THROUGH THE ANUS AND IS INTENDED TO BE AN AID IN THE MANAGEMENT OF FECAL INCONTINENCE. THE CATHETER IS PLACED AND MAINTAINED IN A PERCUTANEOUSLY PREPARED OPENING, SUCH AS A CECOSTOMY. CONTRAINDICATIONS ¿ PREVIOUS ABDOMINAL SURGICAL PROCEDURES... PRECAUTIONS ¿ ¿ 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¿¿ BASED ON THE DMR AND IFU, COOK WAS NOT ABLE TO FIND EVIDENCE SUGGESTING THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION. COOK WAS NOT ABLE TO FIND EVIDENCE OF NONCONFORMING PRODUCT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK WAS NOT ABLE TO ESTABLISH A CAUSE FOR THIS EVENT. NO INFORMATION WAS PROVIDED CONCERNING DEVICE MAINTENANCE WHICH COULD HAVE LED TO THIS EVENT. IT IS POSSIBLE THAT ENOUGH FORCE MAY HAVE BEEN PLACED ON THE DEVICE WHICH MAY HAVE LED TO THIS EVENT. IT IS POSSIBLE THAT IF THE PATIENT HAD AN INCREASE OF BMI, THIS WOULD ALTER THE TRACT SIZING, WHICH COULD INCREASE THE CHANCES OF THE DEVICE BECOMING DISLODGED. HOWEVER, NO TRACT SIZING INFORMATION WAS PROVIDED. THEREFORE, THESE POSSIBILITIES CANNOT BE CONFIRMED. 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, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR 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.
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 PATIENT'S FIRST CECOSTOMY CATHETER WAS PLACED ON (B)(6) 2017. THE CHAIT DEVICE WAS PLACED ON (B)(6) 2019 DURING A ROUTINE EXCHANGE PROCEDURE. THE DEVICE WAS PLACED RELATED TO CONSTIPATION, NEUROPATHIC BOWEL, PARAPLEGIA, AND SPINA BIFIDA. DURING THE PROCEDURE, FLUOROSCOPY IMAGE GUIDANCE WAS USED TO PLACE THE CATHETER PERCUTANEOUSLY IN THE CECUM. THE PROCEDURE AND INITIAL BOWEL EVACUATION WERE SUCCESSFUL. NO DEVICE DEFICIENCIES OR ADVERSE EVENTS WERE IDENTIFIED DURING THE PROCEDURE. WATER AND CASTILLE SOAP WERE INSTILLED THROUGHOUT THE DURATION THE CHAIT REMAINED IN PLACE. A 30-DAY POST PROCEDURE FOLLOW-UP ASSESSMENT WAS NOT PERFORMED. ON (B)(6) 2019 (40 DAYS POST-PROCEDURE), THE PATIENT WAS EMPTYING THEIR CECOSTOMY BAG AND DISCOVERED THE CATHETER HAD DISLODGED AND WAS UNABLE TO REDUCE IT. AS A RESULT, SURGICAL INTERVENTION WAS REQUIRED TO REMOVE AND REPLACE THE DEVICE THE FOLLOWING DAY ((B)(6) 2019). A FOLLOW-UP ASSESSMENT WAS PERFORMED ON (B)(6) 2019 (174 DAYS POST PROCEDURE); NO OTHER ADVERSE EVENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 481741 | CHAIT PERCUTANEOUS CECOSTOMY CATHETER | KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | COOK INC | G12685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention |