PROTOCO2L INSUFFLATION SYSTEM
Report
- Report Number
- 2411512-2013-00006
- Event Type
- Injury
- Date Received
- April 12, 2013
- Report Date
- April 11, 2013
- Manufacturer
- E-Z-EM, INC.
- Product Code
- FCX
- PMA / PMN Number
- K03085
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
NO MALFUNCTION OF THE PROTOCO2L INSUFFLATION DEVICE WAS REPORTED. THE PROTOCO2L INSUFFLATOR DOES NOT PROVIDE FOR INSUFFLATION ABOVE 25MMHG. CO2 GAS IS DISPENSED BY THE DEVICE UNTIL THE GAS PRESSURE REACHES THE SELECTED PRESSURE ON THE DEVICE'S CONTROL PANEL WHICH WAS 25MMGH FOR THIS REPORT. INSUFFLATION THEN STOP UNTIL THE EQUILIBRIUM PRESSURE FALLS BELOW THE 25MMHG AT WHICH TIME ADDITIONAL GAS IS DISPENSED UNTIL THE EQUILIBRIUM PRESSURE OF 25MMHG IS ACHIEVED. THERE ARE ALSO CONTROLS ON THE VOLUME OF GAS DELIVERED. WHEN A TOTAL OF 4 LITERS OF CO2 HAS BEEN DISPENSED, THE UNIT AUTOMATICALLY STOPS. THE USER MUST PRESS THE FLOW/RUN BUTTON ON THE DEVICES FRONT PANEL TO REINITIATE GAS FLOW AND AN ADDITIONAL 2 LITERS OF GAS CAN BE DISPENSED AT WHICH POINT THE UNIT WILL AGAIN AUTOMATICALLY STOP. SUBSEQUENT PRESSES OF THE FLOW/RUN BUTTON ALL DELIVERY OF AN ADDITIONAL 2 LITERS OF GAS. THE PROTOCO2L OPERATOR MANUAL DESCRIBES AUTOMATIC INSUFFLATION AND DOES NOT REFER TO OR PROVIDE ANY INSTRUCTIONS FOR MANUAL INSUFFLATION. BRACCO HAS THEREFORE CODED A VERBATIM TERM "AUTOMATIC AND MANUAL INSUFFLATION - OFF LABEL USE" TO THE PREFERRED MEDDRA TERM "OFF LABEL USE". COMPANY COMMENTS: A (B)(6) MAN WITH A HISTORY OF PULMONARY EMBOLI AND UNEXPLAINED WEIGHT LOS UNDERWENT CT COLONOGRAPHY FOR SUSPECTED MALIGNANCY. INFLATION BEGAN AFTER 1 MG OF GLUCAGON WAS GIVEN SUBCUTANEOUSLY FOLLOWED BY THE INSERTION OF A FLEXI-TIP (E-Z-EM) ENEMA TIP WITH A NON-LATEX RETENTION CUFF. AN ATTEMPT AT ADEQUATE COLONIC INFLATION WAS MADE USING A PROTOCO2L COLON INSUFFLATOR (E-Z EM) SET AT 25 MMHG THRESHOLD CUTOFF VALVE. A CT SCOUT DEMONSTRATED INADEQUATE COLONIC INFLATION, SO THE COLONIC INSUFFLATOR WAS DISCONNECTED. A NURSE INFLATED THE PT MANUALLY, USING CARBON DIOXIDE. A STAFF RADIOLOGIST REVIEWED THE CT COLONOGRAPHY DATE SETS FOLLOWING SCANNING. THE PRONE IMAGES SHOWED COLONIC PERFORATION WITH RESULTING RETROPERITONEAL AND INTRAPERITONEAL FREE AIR. THE PT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. HE WAS DISCHARGED 4 DAYS AFTER ADMISSION FOLLOWING AN UNEVENTFUL HOSPITAL COURSE. THE AUTHORS ALSO NOTED THAT IN THIS CASE, PERICOLONIC AIR WAS OBSERVED IN THE LATERAL CONAL FASCIAL ABOUT THE CECUM, INDICATING THAT THE CECUM WAS THE LIKELY AREA OF PREFORMATION. RUPTURE AT THIS LOCATION, THE AUTHORS FELT, MAY HAVE OCCURRED DUE TO THE RUPTURE OF A DIVERTICULUM, THOUGH NO RIGHT-SIDED DIVERTICULUM WAS SEEN IN THE PT, OR INCREASED WALL STRESS DUE TO THE LARGE DIAMETER OF THE COLON AT THE LOCATION. SINCE THE PORTION OF THE EXAM THAT ACTUALLY USED THE PROTOCO2L DEVICE DID NOT PRODUCE ADEQUATE COLONIC INFLATION AND FREE AIR WAS NOT SEEN ON THE SCOUT SCAN TAKEN AFTER USING THIS DEVICE, IT IS UNLIKELY THAT THE PERFORATION WAS ASSOCIATED WITH THE PROTOCO2L DEVICE. RATHER, IT IS MORE LIKELY THAT THE PERFORATION OCCURRED DURING THE PART OF THE EXAM WHEN THE BOWEL WAS BEING MANUALLY INFLATED BY A NURSE USING A SYRINGE. ADDITIONALLY SINCE THE AREA OF PERFORATION WAS REPORTED TO BE NEAR THE CECUM, THE PERFORATION COULD NOT HAVE BEEN CAUSED BY THE E-Z-EM ENEMA TIP.
NARRATIVE: DUE TO A REQUEST FROM A REGULATORY AUTHORITY, A LITERATURE SEARCH WAS CONDUCTED AND BRACCO BECAME AWARE OF THIS LITERATURE REPORT ON (B)(6) 2013. THIS LITERATURE REPORT WAS PUBLISHED IN (B)(6) 2006. THE FOLLOWING WAS REPORTED IN THE LITERATURE ARTICLE. THE AUTHORS (PHYSICIANS) REPORTED THE FOLLOWING: A (B)(6) MAN WITH A HISTORY OF PULMONARY EMBOLI AND UNEXPLAINED WEIGHT LOSS UNDERWENT CT COLONOGRAPHY FOR SUSPECTED MALIGNANCY. CT COLONOGRAPHY WAS CHOSEN OVER COLONOSCOPY TO MAINTAIN THE PT ON ANTICOAGULATION. CT COLONOGRAPHY INFLATION BEGAN AFTER 1 MG OF GLUCAGON WAS GIVEN SUBCUTANEOUSLY FOLLOWED BY THE INSERTION OF A FLEXI-TIP (E-Z-EM) ENEMA TIP WITH A NONLATEX RETENTION CUFF. THE PT COMPLAINED OF MINIMAL DISCOMFORT RELATED TO THE RECTAL TUBE INSERTION. INITIALLY, AN ATTEMPT AT ADEQUATE COLONIC INFLATION WAS MADE USING A PROTOCO2L COLON INSUFFLATOR (E-Z EM) SET AT 25 MMHG THRESHOLD CUTOFF VALVE, USING CARBON DIOXIDE. A CT SCOUT DEMONSTRATED INADEQUATE COLONIC INFLATION, SO THE COLONIC INSUFFLATOR WAS DISCONNECTED, AND A NURSE EXPERIENCED IN CT COLONOGRAPHY INFLATED THE PT MANUALLY, USING CARBON DIOXIDE. SUPINE CT IMAGES WITH ADEQUATE INFLATION THEN WERE OBTAINED. THE PT WAS ROLLED INTO THE DECUBITUS POSITION, AND MORE CARBON DIOXIDE WAS INSUFFLATED MANUALLY BEFORE PRONE SCANNING. A REPEAT SCOUT CONFIRMED ADEQUATE COLONIC INFLATION AND PRONE CT COLONOGRAPHY IMAGES WERE ACQUIRED. WHILE THE PT COMPLAINED OF MILD PROCEDURE-RELATED DISCOMFORT DURING INSUFFLATION, HE DID NOT COMPLAIN OF ANY PROCEDURE RELATED DISCOMFORT AFTER THE CT COLONOGRAPHY PROCEDURE. A STAFF RADIOLOGIST REVIEWED THE CT COLONOGRAPHY DATA SETS FOLLOWING SCANNING. SUPINE CT COLONOGRAPHY IMAGES DEMONSTRATED A CECAL LIPOMA BUT OTHERWISE NORMAL-APPEARING CECUM AND PERIAPPENDICEAL TISSUES. THE PRONE IMAGES SHOWED COLONIC PERFORATION WITH RESULTING RETROPERITONEAL AND INTRAPERITONEAL FREE AIR. THE PT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. AT ADMISSION, THE PT WAS IN NO DISTRESS, EXPERIENCING ONLY VAGUE LOWER ABDOMINAL PAIN, NONPROGRESSIVE AND NONRADIATING IN NATURE. PHYSICAL EXAMINATION REVEALED AN AFEBRILE PATIENT WITH DIFFUSE LOWER ABDOMINAL TENDERNESS ON PALPATION BUT WITHOUT PALPABLE MASSES. BOWEL SOUNDS WERE PRESENT. THE PT WAS PLACED ON IV ANTIBIOTICS. SUBSEQUENT BOWEL MOVEMENTS WEE ABSENT OF BLOOD AND HIS ABDOMINAL PAIN ABATED. HE WAS DISCHARGED 4 DAYS AFTER ADMISSION FOLLOWING AN UNEVENTFUL HOSPITAL COURSE. IN THE DISCUSSION SECTION OF THE LITERATURE REPORT, THE AUTHORS NOTED THAT THEY HAVE PERFORMED MORE THAN (B)(4) COLONOGRAPHY EXAMINATIONS AT THEIR FACILITY WITHOUT PREVIOUS COMPLICATION. THE AUTHORS ALSO NOTED THAT IN THIS CASE, PERICOLONIC AIR WAS OBSERVED IN THE LATERAL CONAL FASCIA ABOUT THE CECUM, INDICATING THAT THE CECUM WAS THE LIKELY AREA OF PERFORATION. RUPTURE AT THIS LOCATION, THE AUTHORS FELT, MAY HAVE OCCURRED DUE TO THE RUPTURE OF A DIVERTICULUM, THOUGH NO RIGHT-SIDED DIVERTICULUM WAS SEEN IN THE PT, OR INCREASED WALL STRESS DUE TO THE LARGE DIAMETER OF THE COLON AT THE LOCATION. CITATION: YOUNG, BM, FLETCHER, JG, EARNEST, F, FIDLER, JL, MACCARTY, RL, JOHNSON, CD, HUPRICH JE, HOUGH, D. COLONIC PERFORATION AT CT COLONOGRAPHY IN A PT WITHOUT KNOWN COLONIC DISEASE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157861 | PROTOCO2L INSUFFLATION SYSTEM | INSUFFLATOR, AUTOMATIC CARBON DIOXIDE FOR VIRTUAL COLONOSCOPY | FCX | E-Z-EM, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization| O | PROTOCO2L VC ADMINISTRATION SET FOLEY TIP| GLUCAGON (GLUCAGON) (NI TO NOT CONTINUING)| ANTICOAGULATION (NI)| MANUFACTURED FOR E-Z-EM |