CHAIT PERCUTANEOUS CECOSTOMY CATHETER
Report
- Report Number
- 1820334-2023-00771
- Event Type
- Injury
- Date Received
- June 16, 2023
- Report Date
- October 12, 2023
- Manufacturer
- COOK INC
- Product Code
- KNT
- PMA / PMN Number
- K982500
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. UPON FURTHER REVIEW, IT WAS DETERMINED THIS EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY OR REPORTABLE PRODUCT MALFUNCTION. AS REPORTED, THE PATIENTS EXPERIENCED CECOSTOMY TUBE INFECTION AFTER DEVICE PLACEMENT WHICH REQUIRED ORAL ANTIBIOTIC TREATMENT. NO ADDITIONAL PROCEDURES WERE REQUIRED. THIS IS NOT CONSIDERED INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DEATH. THEREFORE, THIS EVENT IS NO LONGER CONSIDERED A SERIOUS INJURY PER 21 CFR PART 803.3. NO DEVICE MALFUNCTION WAS REPORTED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. B3 - DATE OF EVENT: THE DATE OF EVENT OCCURRED BETWEEN (B)(6) 1994 AND (B)(6) 2001. A2 - AGE: PATIENTS WERE BETWEEN 2-23 YEARS OLD. B3 - SEX: 58% MALE (N=95), 42% FEMALE (N=68). B4 - WEIGHT: PATIENTS WEIGHT RANGED FROM 8-72KG. D2A - ADDITIONAL COMMON NAME: EXD IRRIGATOR, OSTOMY. D2B - ADDITIONAL PRODUCT CODE: EXD. D10 - CONCOMITANT PRODUCT: MAJESTIC 18-GAUGE, 7-CM, ONE-WALL NEEDLE WITH A SELDINGER SHIELD (MERIT MEDICAL), 8.5-F, 15-CM LATEX-FREE DAWSON MUELLER MAC-LOC CATHETER (COOK). E1 - CUSTOMER (PERSON): POSTAL CODE: M5G 1X8. 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. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IT WAS REPORTED IN THE LITERATURE ARTICLE, ¿PERCUTANEOUS CECOSTOMY: UPDATES IN TECHNIQUE AND PATIENT CARE (2003),¿ PUBLISHED IN THE JOURNAL RADIOLOGY, THAT EIGHT PATIENTS EXPERIENCED AN INFECTION FOLLOWING DEVICE PLACEMENT THAT REQUIRED ORAL ANTIBIOTIC TREATMENT. "BETWEEN JUNE 1994 AND MARCH 2001, 163 PERCUTANEOUS CECOSTOMY PROCEDURES WERE PERFORMED IN PATIENTS 2¿23 YEARS OLD (MEAN, 10.7 YEARS) WHO RANGED IN WEIGHT FROM 8 TO 72 KG (MEAN, 32.2 KG). THE PATIENT POPULATION CONSISTED OF 95 MALE PATIENTS (58%) AND 68 FEMALE PATIENTS (42%) THIS STUDY WAS APPROVED BY THE RESEARCH ETHICS BOARD AT OUR INSTITUTION. INFORMED CONSENT WAS OBTAINED FROM ALL PARTICIPANTS OR THEIR PARENTS OR GUARDIANS." "IN EVERY CASE, THE INDICATION FOR THE PERCUTANEOUS CECOSTOMY WAS FECAL INCONTINENCE. ALL PATIENTS HAD ONE OF THE FOLLOWING UNDERLYING DIAGNOSES: SPINA BIFIDA OR MENINGOMYELOCELE (N = 106), IMPERFORATE ANUS (INCLUDES PATIENTS WITH VATER SYNDROME [VERTEBRAL AND VASCULAR ANOMALIES, ANAL ATRESIA, TRACHEOESOPHAGEAL FISTULA, ESOPHAGEAL ATRESIA, RENAL ANOMALIES AND RADIAL DYSPLASIA]), SACRAL AGENESIS AND CLOACAL ANOMALIES (N = 53), OR ANOTHER CAUSE OF FECAL INCONTINENCE SUCH AS PARAPLEGIA (N = 1), CEREBRAL PALSY (N = 1), HIRSCHSPRUNG DISEASE (N = 1), OR KLIPPEL-FEIL DEFORMITY (N = 1). REGARDLESS OF THE UNDERLYING DISEASE, THE ANAL SPHINCTER MECHANISM WAS LAX IN ALL PATIENTS. THIS WAS THE MAIN INDICATION FOR PERFORMING THE PROCEDURE. IN ADDITION, 85 (52%) OF THE 163 PATIENTS HAD A VENTRICULOPERITONEAL SHUNT IN PLACE AT THE TIME OF THE CECOSTOMY TUBE PROCEDURE. ALL PATIENTS WITH VENTRICULOPERITONEAL SHUNTS HAD SPINA BIFIDA." "SOME PATIENTS UNDERWENT A BARIUM ENEMA STUDY BEFORE ADMISSION TO DETECT THE POSITION OF THE CECUM. A BARIUM ENEMA STUDY IS RECOMMENDED WHEN THE HISTORY OR IMAGING PERFORMED BEFORE THE PROCEDURE INDICATES VARIANT OR COMPLEX ANATOMY. WE REDUCED THE ADMISSION TIME BEFORE THE PROCEDURE FROM A 1-DAY TO A SAME-DAY ADMISSION BY CHANGING FROM THE NASOGASTRIC ADMINISTRATION OF 25 ML/KG POLY- ETHYLENE GLYCOL ELECTROLYTES TO ORAL ADMINISTRATION OF 45 ML SODIUM PHOSPHATE SOLUTION, WHICH THE PATIENT INGESTED THE NIGHT BEFORE ADMISSION. THE PATIENTS CONSUMED A FLUID DIET FOR 2 DAYS BEFORE THE PERCUTANEOUS CECOSTOMY PROCEDURE. RADIOGRAPHY OF THE ABDOMEN WAS PERFORMED JUST PRIOR TO THE PROCEDURE TO ASSESS BOWEL CLEANSING, AND A REPEAT DOSE OF THE SODIUM PHOSPHATE SOLUTION WAS GIVEN, IF NECESSARY." "THE PROCEDURES WERE PERFORMED BY THREE OF THE AUTHORS (P.G.C., B.L.C., M.J.T.). THE PROCEDURES WERE PERFORMED WITH THE USE OF CONSCIOUS SEDATION IN 138 PATIENTS, GENERAL ANESTHESIA IN 16 PATIENTS, OR LOCAL ANESTHETIC IN NINE PATIENTS. THE PROCEDURE WAS PERFORMED ON A C-ARM FLUOROSCOPIC TABLE WITH TILTING CAPABILITIES. LIMITED ABDOMINAL AND PELVIC ULTRASONOGRAPHY (US) WAS PERFORMED BEFORE THE PROCEDURE TO IDENTIFY FLUID COLLECTIONS AND THE POSITION OF MAJOR ORGANS, INCLUDING THE GALLBLADDER, LIVER, AND URINARY BLADDER. GLUCAGON HYDROCHLORIDE WAS ADMINISTERED INTRAVENOUSLY AT A DOSE OF 0.5¿1.0 MG TO INHIBIT COLONIC PERISTALSIS. AMPICILLIN WAS ADDED TO OUR PROPHYLACTIC ANTIBIOTIC REGIMEN BEFORE AND AFTER THE PROCEDURE. THE ANTIBIOTIC REGIMEN NOW INCLUDES THREE INTRAVENOUSLY ADMINISTERED ANTIBIOTICS: 2.5 MG/KG GENTAMICIN, EVERY 8 HOURS, 10 MG/KG METRONIDAZOLE EVERY 8 HOURS, AND 20 MG/KG AMPICILLIN EVERY 6 HOURS." "THE CECUM WAS DISTENDED WITH AIR BY USING A 22-F SILICONE FOLEY CATHETER [COMPETITOR'S DEVICE] THAT WAS INSERTED THROUGH THE RECTUM. THE BALLOON AT THE TIP OF THE CATHETER WAS INFLATED TO KEEP IT IN POSITION, SINCE THE ANAL OPENING WAS LAX. TO OBTAIN ACCESS, A SINGLE PUNCTURE WAS MADE BY USING FLUOROSCOPIC GUIDANCE WITH AN 18-GAUGE, 7-CM, ONE-WALL NEEDLE WITH A SELDINGER SHIELD [COMPETITOR'S DEVICE]. ONCE ACCESS TO THE CECUM WAS OBTAINED, 5 ML OF CONTRAST MATERIAL WAS INJECTED THROUGH A T-CONNECTOR TO CONFIRM ITS INTRALUMINAL POSITION. THE NEEDLE WAS PRELOADED WITH TWO PEDIATRIC RETENTION SUTURES (ENTEROSTOMY SUTURE ANCHOR SET; COOK, BLOOMINGTON, IND) THAT WERE DEPLOYED INTO THE CECUM WITH A 0.035-INCH AMPLATZ GUIDE WIRE (COOK). THE NEEDLE WAS THEN REMOVED, AND TWO RETENTION SUTURE THREADS WERE CLAMPED WITH MOSQUITO FORCEPS [COMPETITOR'S DEVICE]. THE TRACT WAS DILATED WITH AN 8-F COONS DILATOR (COOK). THIS TECHNIQUE EVOLVED FROM THE INITIAL PROCEDURE, DURING WHICH A 19-GAUGE BSDN NEEDLE (COOK) AND ONE RETENTION SUTURE WERE USED. FOR THE INITIAL CATHETER INSERTION, WE USED AN 8.5-F, 15-CM LATEX-FREE DAWSON MUELLER MAC-LOC CATHETER (COOK); THIS REPLACED THE 10-F COPE-LOOP CATHETER (COOK) THAT WAS PREVIOUSLY USED FOR THIS PROCEDURE AND CONTAINED LATEX." ¿THE CATHETER WAS CONNECTED TO A DRAINAGE BAG INTO WHICH LIQUID DRAINS BY GRAVITY IN ORDER TO ALLOW GAS AND FLUID TO ESCAPE. THIS DECREASED THE PRESSURE IN THE BOWEL, WHICH MAY HELP TO DECREASE THE RISK OF LEAKAGE AROUND THE CECOSTOMY TUBE SITE. THE ANTIBIOTIC REGIMEN WAS CONTINUED WITH THREE INTRAVENOUSLY ADMINISTERED ANTIBIOTICS (AMPICILLIN, GENTAMICIN, METRONIDAZOLE) FOR 48 HOURS AND WAS FOLLOWED BY ORALLY ADMINISTERED METRONIDAZOLE (10 MG/KG EVERY 8 HOURS, AND AS NEEDED) FOR 5 DAYS. ANALGESIA AFTER THE PROCEDURE COMPRISED INTRAVENOUSLY ADMINISTERED MORPHINE (0.05 MG/KG) EVERY 4 HOURS, AS NEEDED, FOR 12 HOURS, FOLLOWED BY ORALLY ADMINISTERED ACETAMINOPHEN (15 MG/KG) EVERY 4 HOURS AND AS NEEDED. PATIENTS WHO WERE FREE OF COMPLICATIONS WERE DISCHARGED WITHIN 2 OR 3 DAYS, WHEREAS THOSE WITH POSTPROCEDURE ILEUS WERE USUALLY DISCHARGED ON THE 5TH OR 6TH DAY AFTER THE PROCEDURE. WHEN EACH PATIENT WAS DISCHARGED FROM THE HOSPITAL, THE DRAINAGE BAG WAS REMOVED ON THE DAY OF DISCHARGE, AND THE PATIENT WAS FLUSHING THE CATHETER TWICE DAILY WITH 5 ML OF SALINE." "A WEEK AFTER THE INSERTION OF THE CECOSTOMY TUBE, ANTEGRADE ENEMAS BEGAN. THE RETENTION SUTURES WERE CUT 10 DAYS AFTER THE PERCUTANEOUS CECOSTOMY PROCEDURE. OUR ANTEGRADE ENEMA ROUTINE UNDERWENT SOME CHANGES. PATIENTS COULD NOW CUSTOMIZE THEIR IRRIGATION PROCEDURE TO THEIR INDIVIDUAL NEEDS RATHER THAN FOLLOW A SET STANDARD. THEY WERE GUIDED IN THIS PROCESS BY A DEDICATED CECOSTOMY NURSE IN OUR INTERVENTIONAL DEPARTMENT. MOST PATIENTS (88 OF 124, 71%) USED A COMBINATION OF SODIUM PHOSPHATE ENEMA AT A DOSE OF 2 ML/KG UP TO A TOTAL DOSE OF 130 ML, FOLLOWED BY SALINE SOLUTION AT A DOSE OF 200¿400 ML, WHICH HAD BEEN PREPARED BY THE PATIENT (10 ML SALT/1 L WATER). PATIENTS WHO EXPERIENCED CRAMPING OR ADVERSE EFFECTS COULD USE OTHER METHODS SUCH AS GLYCERINE (0.5¿1.0 ML/KG) OR BISACODYL, FOLLOWED BY SALINE. PATIENTS ALSO WORKED OUT AN INDIVIDUALIZED IRRIGATION ROUTINE AND USUALLY PERFORMED AN ANTEGRADE ENEMA EVERY 1¿3 DAYS. IF EXCESSIVE SOILING WAS ENCOUNTERED BETWEEN WASH-THROUGHS, PERISTALTIC STIMULANTS SUCH AS SENNOSIDES, LAXATIVES SUCH AS LACTULOSE, OR MINERAL OIL WERE TAKEN ORALLY TO SOFTEN THE STOOL FOR A MORE COMPLETE COLONIC EVACUATION AND CLEANSING." "AFTER 6 WEEKS, THE DAWSON MUELLER MAC-LOC CATHETER WAS EXCHANGED FOR A LOW-PROFILE CHAIT TRAPDOOR CECOSTOMY CATHETER (COOK). THIS EXCHANGE WAS PERFORMED OVER A WIRE WITH FLUOROSCOPIC GUIDANCE. NO SEDATION OR ANTIBIOTIC COVERAGE WAS NECESSARY, AND THE PROCEDURE WAS PERFORMED ON AN OUTPATIENT BASIS. OUR INITIAL ROUTINE INVOLVED REPLACING THE CHAIT TRAPDOOR CATHETERS ONLY WHEN PROBLEMS AROSE; HOWEVER, WE NOW SUGGEST YEARLY CHANGES OF THIS CATHETER. FOR THIS PROCEDURE, WE FOUND IT EASIER TO CUT THE OLD CATHETER BELOW THE ¿TRAPDOOR¿ AND ADVANCE THE NEW CATHETER OVER A WIRE. THIS DISPLACED THE DISTAL PART OF THE OLD CATHETER, INCLUDING THE DISTAL PIGTAIL COILS, INTO THE CECUM, WHERE THEY WERE THEN PASSED EASILY THROUGH THE RECTUM." "BECAUSE THERE ARE A WIDE RANGE OF PATIENT SIZES, TWO SIZES OF CHAIT TRAPDOOR CATHETERS ARE NOW AVAILABLE. THIS ALLOWS BETTER CUSTOMIZATION FOR INDIVIDUAL PATIENTS. THE SMALLER CATHETER WAS USED IN SMALLER OR THINNER PATIENTS, AND THE LARGER CATHETER, WHICH HAS A 7-CM STRAIGHT PORTION BEFORE THE DISTAL COIL, WAS USED IN LARGER PATIENTS. THE DECISION ON WHICH SIZE TO USE WAS BASED ON THE DISTANCE FROM THE SKIN TO THE CECUM. THIS CAN USUALLY BE SEEN FROM THE LENGTH OF THE 15-CM DAWSON MUELLER MAC-LOC CATHETER THAT IS ON THE OUTSIDE OF THE SKIN." "OTHER CATHETERS USED BY A SMALL NUMBER OF PATIENTS INCLUDE [A COMPETITOR'S CECOSTOMY CATHETER], THE DAWSON-MUELLER MAC-LOC CATHETER, AND [A COMPETITOR'S ENEMA BUTTON CATHETER]." "THE LONG-TERM CARE OF THE CECOSTOMY PATIENTS WAS PERFORMED BY A TEAM COMPRISING A PEDIATRIC INTERVENTIONAL RADIOLOGIST, A GENERAL SURGEON, A PEDIATRICIAN, AND A CECOSTOMY NURSE." "INFORMATION WAS COLLECTED REGARDING DIFFERENT ASPECTS OF THE PROCEDURE, INCLUDING THE DURATION THE CECOSTOMY TUBE HAD BEEN IN SITU OR THE REASON FOR ITS REMOVAL, THE TYPE OF CATHETER USED, THE GOAL OR THE REASON FOR UNDERGOING THE PROCEDURE AND IF THAT GOAL WAS MET, ANY PROBLEMS OR COMPLICATIONS REGARDING THE CECOSTOMY PROCEDURE, THE FREQUENCY OF IRRIGATION, THE EFFECT OF THE PROCEDURE ON THE FREQUENCY OF SOILING ACCIDENTS, THE SATISFACTION WITH THE PROCEDURE, AND WHETHER THE PATIENT WOULD RECOMMEND THE PROCEDURE TO OTHERS. THIS INFORMATION WAS OBTAINED BY INTERVIEWING EITHER THE PATIENTS OR THEIR PARENTS AS APPROPRIATE TO THE AGE OF THE PATIENT AND HIS OR HER UNDERSTANDING. INTERVIEWS WERE CONDUCTED EITHER IN PERSON OR BY TELEPHONE. THE QUESTIONS ASKED WERE IDENTICAL IN ALL INTERVIEWS AND WERE READ FROM A QUESTIONNAIRE THAT WAS PREPARED BY THE AUTHORS. ABSTRACT QUESTIONS SUCH AS THE PATIENT¿S LEVEL OF SATISFACTION WITH THE PROCEDURE WERE GRADED BY THE INTERVIEWEE ON A QUALITATIVE SCALE BETWEEN ¿VERY UNSATISFIED¿ AND ¿VERY SATISFIED.¿ ALL INTERVIEWS WERE PERFORMED BY A SINGLE AUTHOR (E.S.)." "LONG-TERM RESULTS AND FOLLOW-UP WERE OBTAINED FROM 124 (76%) OF THE 163 PATIENTS. THE REMAINING 39 PATIENTS WERE LOST TO FOLLOW-UP." "AMONG THE PATIENTS WHO UNDERWENT A CECOSTOMY, THERE WAS ONE DEATH, WHICH WAS UNRELATED TO THE CECOSTOMY PROCEDURE (THE PATIENT DIED OF PNEUMONIA 5 YEARS AFTER THE CECOSTOMY PROCEDURE). THE CECOSTOMY TUBE WAS SUCCESSFULLY PLACED IN ALL PATIENTS. IN THE PATIENT WITH HIRSCHSPRUNG DISEASE, THE TUBE WAS REMOVED AFTER 90 DAYS BECAUSE OF VOMITING. FOUR OTHER PATIENTS ELECTED TO HAVE THEIR CATHETERS REMOVED DUE TO CATHETER MAINTENANCE (POOR PATIENT COMPLIANCE) (N = 2) OR AESTHETIC CONSIDERATIONS (N = 2)." "THE MOST WIDELY USED LONG-TERM CATHETER FOR THE CECOSTOMY PROCEDURE IN THIS STUDY POPULATION WAS THE CHAIT TRAPDOOR CATHETER, WHICH WAS USED IN 111 (90%) OF THE 124 PATIENTS. THE [A COMPETITOR'S CECOSTOMY CATHETER] AND DAWSON-MUELLER MAC-LOC CATHETER WERE EACH USED IN SIX (4%) OF THE 124 PATIENTS. FINALLY, [A COMPETITOR'S ENEMA BUTTON CATHETER] WAS USED IN ONE PATIENT. THE CECOSTOMY CATHETERS WERE IN SITU FOR AN AVERAGE OF 3.1 YEARS (RANGE, 2¿73 MONTHS). THE TWO MAIN REASONS EXPRESSED BY PATIENTS OR PARENTS FOR UNDERGOING A CECOSTOMY PROCEDURE WERE TO DECREASE THE NUMBER OF SOILING ACCIDENTS AND TO INCREASE BOTH THE PATIENT¿S INDEPENDENCE IN PERFORMING THE BOWEL CONTROL PROCEDURE AND THE PATIENT¿S OVERALL INDEPENDENCE. NINETY-EIGHT (79%) OF THE 124 PATIENTS REPORTED THEY ACHIEVED THEIR MAIN GOAL AFTER UNDERGOING THE CECOSTOMY PROCEDURE." "SEVENTY-FOUR (60%) OF THE 124 PATIENTS EXPERIENCED SOME CECOSTOMY TUBE RELATED PROBLEMS AT SOME POINT DURING THE FOLLOW- UP PERIOD; HOWEVER, MOST WERE MINOR AND DID NOT NECESSITATE MEDICAL INTERVENTION. IN EIGHT (6%) OF THE 124 PATIENTS, A CECOSTOMY TUBE INFECTION OCCURRED, WHICH REQUIRED ORAL ANTIBIOTIC TREATMENT. CECOSTOMY TUBE FAILURE OCCURRED IN 12 (10%) OF THE 124 PATIENTS. THESE INCLUDED THE UNCOILING OF THE TUBE INSIDE THE BODY IN TWO (2%) OF THE PATIENTS AND TUBE BREAKAGE IN 10 (8%) OF THE PATIENTS. IN 18 (14%) OF THE 124 PATIENTS, REINSERTION OF THE CECOSTOMY TUBE WAS REQUIRED, MOSTLY AS A RESULT OF ACCIDENTAL REMOVAL OF THE TUBE. A NUMBER OF PATIENTS EXPERIENCED MINOR DIFFICULTIES RELATED TO THE CECOSTOMY TUBE, INCLUDING SLIGHT CLOGGING OF THE CECOSTOMY TUBE AND PARTIAL DISLODGMENT OF THE TUBE. THESE PROBLEMS WERE EASILY CORRECTED AT HOME AND DID NOT REQUIRE MEDICAL INTERVENTION." "THE DEVELOPMENT OF GRANULATION TISSUE ACCOMPANIED WITH REDNESS AT THE CECOSTOMY SITE APPEARED AT ONE TIME OR ANOTHER IN 75 (60%) OF THE 124 PATIENTS AND WAS NOT ACCOMPANIED WITH ANY PAIN OR DISCOMFORT AT THE TUBE SITE. THE GRANULATION TISSUE WAS PERIODICALLY ACCOMPANIED WITH A DISCHARGE, WHICH WAS USUALLY COLORLESS OR SLIGHTLY YELLOW AND ODORLESS. THIS WAS TREATED BY MEANS OF CAUTERIZATION WITH SILVER NITRATE. ANTEGRADE ENEMAS WERE ADMINISTERED ACCORDING TO THE NEEDS OF THE PATIENT (RANGE, EVERY 1¿7 DAYS; MEAN, EVERY 2.4 DAYS). THE VAST MAJORITY OF PATIENTS (110 OF 124, 89%) REPORTED A DECREASE IN THE FREQUENCY OF SOILING ACCIDENTS AFTER THE PROCEDURE COMPARED WITH THE FREQUENCY BEFORE THE PROCEDURE. A THIRD OF THE PATIENTS NOW EXPERIENCE FEWER THAN ONE SOILING ACCIDENT PER 6 MONTHS. THE VAST MAJORITY OF PATIENTS (116 OF 124, 94%) EXPRESSED SATISFACTION WITH THE PROCEDURE. ACCORDING TO OUR RESULTS, 117 (94%) OF THE 124 PATIENTS RATED THE CECOSTOMY PROCEDURE AS BETTER THAN THE IRRIGATION OR BOWEL CONTROL PROCEDURE THAT THEY USED BEFORE, AND THEY WERE SATISFIED WITH ITS EFFECTIVENESS. ONE HUNDRED TWENTY (97%) OF THE 124 PATIENTS SAID THAT THEY WOULD RECOMMEND THE CECOSTOMY PROCEDURE TO OTHERS IN THEIR SITUATION." THE REPORT CAPTURES EIGHT (6%) OF PATIENTS THAT DEVELOPED A CECOSTOMY TUBE INFECTION THAT REQUIRED ORAL ANTIBIOTIC TREATMENT. LITERATURE CITATION: CHAIT, P. G., SHLOMOVITZ, E., CONNOLLY, B. L., TEMPLE, M. J., RESTREPO, R., AMARAL, J. G., MURACA, S., RICHARDS, H. F., & EIN, S. H. (2003). PERCUTANEOUS CECOSTOMY: UPDATES IN TECHNIQUE AND PATIENT CARE. RADIOLOGY, 227(1), 246¿250. HTTPS://DOI.ORG/10.1148/RADIOL.2271020574.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710120 | CHAIT PERCUTANEOUS CECOSTOMY CATHETER | KNT TUBES, GASTROINTESTINAL | KNT | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | 10-F COPE-LOOP CATHETER (COOK)| 19-GUAGE BSDN NEEDLE (COOK)| 22-F SILICONE FOLEY CATHETER (RUSCH-PILLING)| 8FR COONS DILATOR (COOK)| AMPLATZ WIRE GUIDE (COOK)| ENTEROSTOMY SUTURE ANCHOR SET (COOK)| MOSQUITO HEMOSTATIC FORCEPS (KMEDIC) |