BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOCO2L INSUFFLATION SYSTEM

    MDR report key: 3070573 · Received April 12, 2013

    Report

    Report Number
    2411512-2013-00007
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    January 1, 2004
    Report Date
    April 12, 2013
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FCX
    PMA / PMN Number
    K030854
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRAND NAME OR MANUFACTURE OF THE PEDIATRIC TIP WAS NOT REPORTED. NO MALFUNCTION OF THE PROTOCO2L INSUFFLATION DEVICE WAS REPORTED. CO2 GAS IS DISPENSE BY PROTOCO2L DEVICE UNTIL THE GAS PRESSURE REACHES THE SELECTED PRESSURE ON THE DEVICE'S CONTROL PANEL WHICH WAS 25MMHG FOR THIS REPORT. INSUFFLATION THEN STOPS UNTIL THE EQUILIBRIUM PRESSURE FALLS BELOW THE 25MMHG AT WHICH TIME ADDITIONAL GAS IS DISPENSED UNTIL THE EQUILIBRIUM PRESSURE OF 25MMGH IS REACHIEVED. THE PROTOCO2L HAS REDUNDANT PRESSURE RELIEF VALVES INCLUDING ELECTRICAL AND MECHANICAL PRESSURE RELIEF VALVES TO PREVENT AN OVER PRESSURE SITUATION. 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 AND THEN UNIT WILL AGAIN AUTOMATICALLY STOP. SUBSEQUENT PRESSES OF THE FLOW/RUN BUTTON WILL ALLOW DELIVERY OF AN ADDITIONAL 2 LITERS OF GAS. THE OPERATOR'S MANUAL FOR THE PROTOCO2L PROVIDES THE FOLLOWING INSTRUCTION IN THE INDICATIONS AND CONTRAINDICATIONS SECTION. "DO NOT USE THIS PRODUCT FOLLOWING RECENT RECTAL SURGERY OR LOW RECTAL ANASTOMOSIS, OR WHEN PROCTITIS OR OTHER RECTAL CONDITIONS SUCH AS INFLAMMATORY OR NEOPLASTIC DISEASES ARE SUSPECTED". COMPANY COMMENTS: A 47-YEAR-OLD FEMALE WITH A HISTORY OF ABDOMINAL PAIN, WEIGHT LOSS, DIARRHEA AND CROHN'S DISEASE OF THE ILEUM WITH ABSCESS FORMATION, ILEOCECAL RESECTION, A TIGHT RECTAL STRICTURE DILATION PROCEDURE, AND MODERATE TO SERVE INFLAMMATION THROUGHOUT THE FORSCHORTENDED COLON WITH SKIP LESIONS, STRICTURES, AND MODERATE COLITIS UNDERWENT A COMPUTED COLONOGRAPHY PROCEDURE TO ASSESS THE GASTRO INTESTINAL TRACT. DUE TO THE RECTAL STRICTURE, A PEDIATRIC TIP WAS USED FOR RECTAL AIR INSUFFLATION AND A RECTAL BALLOON WAS NOT INFLATED. AN AUTOMATED CARBON DIOXIDE INSUFFLATOR WAS USED TO INFLATE THE COLON. AFTER APPROXIMATELY ONE LITER OF GAS WAS ADMINISTERED, A SCOUT FILM WAS OBTAINED. THE SCOUT FILM DEMONSTRATED FREE RETROPERITONEAL AIR UPON EVALUATION BY THE RADIOLOGIST AND A NON-CONTRAST CT WAS OBTAINED. THE CT DEMONSTRATED A LARGE AMOUNT OF FREE RETROPERITONEAL AIR EXTENDING FROM THE ILEO ASCENDING ANASTOMOSIS REGION AND SURROUNDING THE ASCENDING COLON AND DESCENDING DUODENUM. EXTRALUMINAL LEAKAGE WAS NOTED IN THE RIGHT COLON, APPROXIMATELY 5 CM DISTAL TO THE PRIOR ILEOASCENDING ANASTOMOSIS, ALONG WITH STRICTURES IN THE SIGMOID AND TRANSVERSE COLON. AT SURGERY, THE SITE OF PERFORATION WAS CONFIRMED JUST DISTAL TO THE PREVIOUS ILEOASCENDING ANASTOMOSIS, AND APPEARED CONTAINED IN THE RETROPERITONEUM. ADDITIONALLY, A LARGE PHLEGMON IN THE REGION OF THIS ANASTOMOSIS WAS NOTED, ALONG WITH DIFFUSELY DISEASED ASCENDING COLON. THE PERFORATION WAS CLOSED AND A DIVERTING LOOP ILEOSTOMY WAS FORMED. THE PT'S POSTOPERATIVE COURSE WAS UNEVENTFUL, AND SHE WAS DISCHARGED ON HOSPITAL DAY NUMBER SEVEN. THE REPORTER CONCLUDED THAT THE PERFORATION LIKELY OCCURRED DUE TO BAROTRAUMAS IN THE SETTING OF COLONIC STRICTURES AND INFLAMED AND WEAKENED COLONIC WALL. THE CONCLUSION OF THE REPORTER IS APPROPRIATE AND WITHOUT AND ALTERNATIVE EXPLANATIONS CAUSALITY CANNOT BE EXCLUDED.

    Description of Event or Problem · 1

    NARRATIVE: DUE TO A REQUEST FROM A REGULATORY AUTHORITY, A LITERATURE SEARCH WAS CONDUCTED AND BRACCO BECAME AWARE OF THIS LITERATURE REPORT ON 03/24/2013. THIS LITERATURE REPORT WAS PUBLISHED IN 2006. THE AUTHORS (PHYSICIANS) REPORTED THE FOLLOWING: A 47-YEAR-OLD FEMALE INITIALLY PRESENTED TO OUR FACILITY IN 1997 FOR OUTPATIENT MANAGEMENT OF ABDOMINAL PAIN, WEIGHT LOSS, AND DIARRHEA RELATED TO (CROHN'S DISEASE (CD). IN 1987, AFTER YEARS OF UNDIAGNOSED SYMPTOMS, THE PT WAS FOUND TO HAVE CD OF THE ILEUM WITH ABSCESS FORMATION, WHICH WAS TREATED BY ILEOCECAL RESECTION. SYMPTOMS WERE STABLE FROM 1987 TO 1995, BUT DIARRHEA THEN RECURRED, AND THE PT TURNED TO "ALTERNATIVE MEDICINE" THERAPIES FOR 2 YEARS PRIOR TO SEEKING TREATMENT AT OUR FACILITY. THE PT WAS INTOLERANT OF AMINOSALICYLATE PRODUCTS (HEADACHES, HIVES, LOW-GRADE FEVERS), 6-MERCAPTOPURINE (EXTREME FATIGUE, EMOTIONAL LIABILITY) AND AZATHIOPRINE (FATIGUE, SUBJECTIVE FEVER). METRONIDAZOLE TREATMENT WAS HELPFUL FOR 6 MONTHS, BUT SYMPTOMS OF DIARRHEA AND ABDOMINAL PAIN AGAIN RETURNED. INFLIXIMAB THERAPY WAS SUBSEQUENTLY INITIATED WITH GOOD INITIAL RESPONSE BUT PROMPT SYMPTOM RECURRENCE. AN ATTEMPTED COLONOSCOPY IN 09/2001 REVEALED A TIGHT LOW RECTAL STRICTURE, WHICH REQUIRE DILATION UNDER ANESTHESIA BY A COLORECTAL SURGEON. SUBSEQUENT COLONOSCOPY REVEALED MODERATE TO SEVERE INFLAMMATION THROUGHOUT THE FORESHORTENED COLON WITH SKIP LESIONS. A STRICTURE FROM 25 TO 40 CM WAS IDENTIFIED AND WAS ONLY PASSABLE WITH AN 8.6 MM DIAMETER UPPER ENDOSCOPE. AN ADDITIONAL STRICTURE AT THE ILEOASCENDING ANASTOMOSIS PRECLUDED ILEAL INTUBATION. PATHOLOGY SPECIMENS FROM THROUGHOUT THE COLON DEMONSTRATED MODERATE COLITIS WITH FOCALITY CONSISTENT WITH CROHN'S DISEASE. A REPEAT TRIAL OF INFLIXIMAB WITH STEROID AND ANTIHISTAMINE PREMEDICATION WAS COMPLICATED BY A SEVERE SYSTEMIC INFUSION REACTION AFTER 6 MONTHS OF USE. INFLIXIMAB WAS DISCONTINUED, AND THE PT WAS THEN TREATED ON AN EXPERIMENTAL INTERLEUKIN-11 PROTOCOL FOR 6 MONTHS WITHOUT SIGNIFICANT IMPROVEMENT. THE PT DECLINED METHOTREXATE THERAPY OR OTHER EXPERIMENTAL PROTOCOLS. SHE INITIATED "ALTERNATIVE THERAPIES " INCLUDING HERBAL MEDICATIONS AND VITAMIN SUPPLEMENTS, AND WAS SUBSEQUENTLY LOST TO FOLLOW-UP FOR 2 YR. IN 2004, THE PT REPRESENTED TO OUR CLINIC WITH DIARRHEA, INCOMPLETE EVACUATION, AND STRAINING AT STOOL AND REQUESTED EVALUATION OF HER COLON. IN AN EFFORT TO PLAN FOR A COMBINED ENDOSCOPIC EVALUATION AND POSSIBLE STRICTURE DILATION, AS WELL AS TO ASSESS THE REMAINDER OF THE GASTROINTESTINAL TRACT, A CTC WAS ORDERED AS THE INITIAL DIAGNOSTIC TEST. DUE TO THE RECTAL STRICTURE, A PEDIATRIC TIP WAS USED FOR RECTAL AIR INSUFFLATION AND A RECTAL BALLOON WAS NOT INFLATED. AN AUTOMATED CARBON DIOXIDE INSUFFLATOR WAS USED TO INFLATE THE COLON. AFTER APPROXIMATELY 1 L OF GAS WAS ADMINISTERED, SA SCOUT FILM WAS OBTAINED AT THE SUGGESTION OF THE NURSE WHO THOUGHT THE "PT LOOKED FUNNY" ALTHOUGH THE PT, WHEN ASKED, DENIED ANY ABDOMINAL PAIN. RECTAL GAS ADMINISTRATION WAS STOPPED. THE SCOUT FILM DEMONSTRATED FREE RETROPERITONEAL AIR UPON EVALUATION BY THE RADIOLOGIST AND A NON-CONTRAST CT WAS OBTAINED. THE CT DEMONSTRATED A LARGE AMOUNT OF FREE RETROPERITONEAL AIR (FIG. 1) EXTENDING FROM THE ILEO ASCENDING ANASTOMOSIS REGION AND SURROUNDING THE ASCENDING COLON AND DESCENDING DUODENUM. THE PT WAS ADMITTED TO THE HOSPITAL AND STARTED ON BROAD-SPECTRUM ANTIBIOTICS. AS THE SITE OF PERFORATION WAS NOT CLEAR ON CT, THE PT WAS GIVEN A WATER SOLUBLE CONTRAST ENEMA TO IDENTIFY THE SITE (FIG. 2). EXTRALUMINAL LEAKAGE WAS NOTED IN THE RIGHT COLON, APPROXIMATELY 5 CM DISTAL TO THE PRIOR ILEOASCENDING ANASTOMOSIS, ALONG WITH STRICTURES IN THE SIGMOID AND TRANSVERSE COLON. A REPEAT CT OF THE ABDOMEN OBTAINED FOLLOWING THE ENEMA CONFIRMED THE CONTRAST LEAK AND DEMONSTRATED CIRCUMFERENTIAL BOWEL WALL THICKENING AND NARROWING IN LONG SEGMENTS OF THE SIGMOID COLON, TRANSVERSE COLON, AND NEOTERMINAL ILEUM (FIG. 3). AFTER CAREFUL DISCUSSION BETWEEN THE COLORECTAL SURGERY SERVICE AND THE PT AND HER FAMILY, THE DECISION WAS MADE TO PROCEED WITH EXPLORATORY LAPAROTOMY. AT SURGERY, THE SITE OF PERFORATION WAS CONFIRMED JUST DISTAL TO THE PREVIOUS ILEOASCENDING ANASTOMOSIS, AND APPEARED CONTAINED IN THE RETROPERITONEUM. ADDITIONALLY, A LARGE PHLEGMON IN THE REGION OF THIS ANASTOMOSIS WAS NOTED, ALONG WITH DIFFUSELY DISEASED ASCENDING COLON. THE REMAINING SMALL BOWEL AND COLON WERE PALPATED UNDER FLUID AND DEMONSTRATED NO ADDITIONAL SITES OF PERFORATION. THE PERFORATION WAS CLOSED WITH TWO SUTURE LAYERS, AND A DIVERTING LOOP ILEOSTOMY WAS FORMED 15 CM PROXIMAL TO THE ILEOASCENDING ANASTOMOSIS. THE PT'S POSTOPERATIVE COURSE WAS UNEVENTFUL, AND SHE WAS DISCHARGED ON HOSPITAL DAY NUMBER SEVEN. SHE WAS INITIATED ON A PREDNISONE TAPER AND AZATHIOPRINE AS AN OUTPATIENT IN AN EFFORT TO REDUCE INFLAMMATION PRIOR TO RESTORING INTESTINAL CONTINUITY. THE REPEAT TRIAL OF AZATHIOPRINE WAS AGAIN NOT TOLERATED AND WAS DISCONTINUED. COLONOSCOPY WAS PERFORMED 3 MONTHS POSTOPERATIVELY REVEALING STRICTURES AT THE RECTOSIGMOID JUNCTION AND SIGMOID DESCENDING COLON JUNCTION, ALONG WITH MILD RECTAL INFLAMMATION. THE RECTOSIGMOID STRICTURE WAS SUCCESSFULLY DILATED TO 13.5 MM IN THE HOPES OF ALLOWING FOR A MORE PROXIMAL ILEOCOLONIC ANASTOMOSIS. BIOPSIES FROM BOTH STRICTURES WERE NEGATIVE FOR DYSPLASIA. AT SURGERY TO REESTABLISH INTESTINAL CONTINUITY 3 WEEKS LATER, THE TERMINAL ILEUM WITH ASSOCIATED PHLEGMON WAS RESECTED ALONG WITH CHRONICALLY INFLAMED ASCENDING, TRANSVERSE AND DESCENDING COLON, AND AN ILEOSIGMOID ANASTOMOSIS WAS FORMED JUST DISTAL TO THE SIGMOID STRICTURE. CITATION: TRIESTER STUART L, HARA AMLY K, YOUNG-FADOK TONIA M., HEIGHT, RUSSELL I. COLONIC PERFORATION AFTER COMPUTED TOMOGRAPHIC COLONOGRAPHY IN A PT WITH FIBROSENOSING CHRN'S DISEASE./AMERICAN JOURNAL OF GASTROENTEROLOGY 2006; 101: 189 TO 192. WORLD WIDE CASE ID: US-BRACCO-000067-MD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159732 PROTOCO2L INSUFFLATION SYSTEM INSUFFLATOR, AUTOMATIC CARBON DIOXIDE FOR VIRTUAL COLONSCOPY FCX E-Z-EM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O