CHAIT PERCUTANEOUS CECOSTOMY CATHETER
Report
- Report Number
- 1820334-2025-00686
- Event Type
- Injury
- Date Received
- June 10, 2025
- Date of Event
- November 19, 2020
- Report Date
- December 15, 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
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.
INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT A CHAIT PERCUTANEOUS CECOSTOMY CATHETER LEAKED. THE FIRST CECOSTOMY CATHETER WAS PLACED ON (B)(6) 2017. THE CHAIT DEVICE WAS PLACED ON (B)(6) 2020 DURING A ROUTINE EXCHANGE PROCEDURE. THE DEVICE WAS PLACED RELATED TO SEVERE CHRONIC CONSTIPATION, NEUROPATHIC BOWEL, 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 PHOSPHATE ENEMA WERE INSTILLED THROUGHOUT THE DURATION THE CHAIT REMAINED IN PLACE. A 30-DAY POST PROCEDURE FOLLOW-UP ASSESSMENT WAS NOT PERFORMED. ON (B)(6) 2020 (141 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED DEVICE LEAKAGE AND PAIN WITH FLUSHING. AS A RESULT, SURGICAL INTERVENTION WAS REQUIRED TO REMOVE AND REPLACE THE DEVICE. THE PATIENT HAD AN ADDITIONAL FOLLOW-UP ON 02DEC2020. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF DOCUMENTATION INCLUDING THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES 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 FOR THIS CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. COOK ALSO REVIEWED PRODUCT LABELING. THE INSTRUCTIONS FOR USE (IFU) [T_TDCS_REV7] SUPPLIED WITH THE COMPLAINT RPN WAS REVIEWED FOR INFORMATION RELATED TO THE REPORTED FAILURE MODE. THE IFU STATES: ¿CONTRAINDICATIONS: ¿ PREVIOUS ABDOMINAL SURGICAL PROCEDURES. PRECAUTIONS. ¿ INSTRUCT THE PATIENT TO READ AND UNDERSTAND THE PATIENT GUIDE TITLED ¿CARING FOR YOUR TEMPORARY & CHAIT TRAPDOOR CECOSTOMY CATHETERS¿ PRIOR TO INITIAL CATHETER INTRODUCTION. ¿PATIENT INSTRUCTIONS FOR MAINTENANCE OF CHAIT TRAPDOOR CECOSTOMY CATHETER NOTE: INSTRUCT THE PATIENT TO READ AND UNDERSTAND THE PATIENT GUIDE TITLED ¿CARING FOR YOUR TEMPORARY & CHAIT TRAPDOOR CECOSTOMY CATHETERS¿ PRIOR TO INITIAL CATHETER INTRODUCTION. 5. AFTER USE, PATIENT SHOULD REMOVE CONNECTING TUBE AND PIN FROM TRAPDOOR FITTING, AND CLOSE FITTING TO PREVENT LEAKAGE.¿ 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 DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, COOK WAS NOT ABLE TO ESTABLISH A CAUSE FOR THIS EVENT. IT IS POSSIBLE THAT THE PATIENT¿S PRE-EXISTING CONDITIONS AND PREVIOUS ABDOMINAL PROCEDURES CONTRIBUTED TO THE EVENT. HOWEVER, THIS CANNOT 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, 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.
CORRECTION: THE ORIGINAL PROVIDED LOT WAS INCORRECT. D4: LOT # AND EXPIRATION DATE; H4: DEVICE MFG DATE ARE ALL UNKNOWN. 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.
IT WAS REPORTED THAT A CHAIT PERCUTANEOUS CECOSTOMY CATHETER LEAKED. THE FIRST CECOSTOMY CATHETER WAS PLACED ON (B)(6) 2017. THE CHAIT DEVICE WAS PLACED ON (B)(6) 2020 DURING A ROUTINE EXCHANGE PROCEDURE. THE DEVICE WAS PLACED RELATED TO SEVERE CHRONIC CONSTIPATION, NEUROPATHIC BOWEL, 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 PHOSPHATE ENEMA WERE INSTILLED THROUGHOUT THE DURATION THE CHAIT REMAINED IN PLACE. A 30-DAY POST PROCEDURE FOLLOW-UP ASSESSMENT WAS NOT PERFORMED. ON (B)(6) 2020 (141 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED DEVICE LEAKAGE AND PAIN WITH FLUSHING. AS A RESULT, SURGICAL INTERVENTION WAS REQUIRED TO REMOVE AND REPLACE THE DEVICE. THE PATIENT HAD AN ADDITIONAL FOLLOW-UP ON (B)(6) 2020; NO OTHER ADVERSE EVENTS WERE REPORTED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 494772 | CHAIT PERCUTANEOUS CECOSTOMY CATHETER | KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | COOK INC | G12685 | 10266832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Male | Required Intervention |