BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZEM PROTOCOL CO2 L COLON INSUFFLATOR UNIT

    MDR report key: 3142484 · Received April 22, 2013

    Report

    Report Number
    2411512-2013-00009
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BRACCO UK LTD.
    Product Code
    FCX
    PMA / PMN Number
    K030854
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE MOMENT THERE IS NOT ENOUGH INFORMATION AVAILABLE TO CONCLUDE THAT CECUM PERFORATION HAD OCCURRED DUE TO THE CO2 INSUFFLATION WITH THE EZEM PROTOCOL CO2 INSUFFLATOR. THE PATIENT WAS ENTIRELY ASYMPTOMATIC AND THE ONLY SIGN WAS INCIDENTALLY DISCOVERED BY RADIOLOGIST EXTRA-LUMINAL GAS ASSOCIATED WITH LUMINAL PERFORATION. ADDITIONALLY IT IS NOT CERTAIN THAT BRACCO EZEM PROTOCOL CO2 INSUFFLATOR WAS USED. THEREFORE, WITH THE INFORMATION ON HAND THE EVENT IS CONSIDERED NOT REPORTABLE. COMPANY COMMENTS: A PATIENT OF UNSPECIFIED DEMOGRAPHY UNDERWENT A CT COLONOGRAPHY WITH A RETENTION BALLOON CATHETER AND AN AUTOMATED CO2 INSUFFLATION DEVICE. BETWEEN SIX HOURS AND FOUR DAYS AFTER THE PROCEDURE THE RADIOLOGIST INCIDENTALLY DISCOVERED EXTRA-LUMINAL GAS ASSOCIATED WITH LUMINAL PERFORATION. THE EXACT SITE OF THE PERFORATION WAS DIFFICULT TO ESTABLISH, BECAUSE NO OBVIOUS CAUSE OF THE PERFORATION WAS ATTRIBUTED. HOWEVER, EXTRA-LUMINAL GAS WAS LOCATED INTRAPERITONEALLY SURROUNDING THE CECUM. THE PATIENT WAS ENTIRELY ASYMPTOMATIC PERFORATION WAS DIFFICULT TO ESTABLISH, BECAUSE NO OBVIOUS CAUSE OF THE PERFORATION WAS ATTRIBUTED. HOWEVER, EXTRA-LUMINAL GAS WAS LOCATED INTRAPERITONEALLY SURROUNDING THE CECUM. THE PATIENT WAS ENTIRELY ASYMPTOMATIC AND FELT WELL AND HE/SHE TREATED AT HOME CONSERVATIVELY. ASYMPTOMATIC COLONIC PERFORATION HAS BEEN VERY RARELY OBSERVED DURING CT COLONOGRAPHY. IN THIS CASE IT WAS NOT CONFIRMED THAT THE EZEM CO2 INSUFFLATOR WAS USED. THEREFORE, A RELATIONSHIP BETWEEN THE EZEM CO2 INSUFFLATOR AND THE LUMINAL PERFORATION IS UNASSESSABLE.

    Description of Event or Problem · 1

    NARRATIVE: MARCH 24, 2013: DUE TO A REQUEST FROM A REGULATORY AUTHORITY, A LITERATURE SEARCH WAS CONDUCTED AND BRACCO (B)(4) BECAME AWARE OF THIS LITERATURE CASE WHICH WAS FORWARDED TO (B)(4) (OPERATING ON BEHALF OF BRACCO) ON MARCH 29, 2013. IN 2005 A NATIONAL SURVEY WAS CONDUCTED TO EVALUATE COMPLICATIONS ASSOCIATED WITH CT COLONOGRAPHY. A TELEPHONE QUESTIONNAIRE WAS CONDUCTED IN 50 CENTERS CONCERNING 17067 CT COLONOGRAPHY EXAMINATIONS IN PATIENTS WITH SYMPTOMS OF COLORECTAL CANCER (E.G. CHANGE IN BOWEL HABITS, RECTAL BLEEDING AND WEIGHT LOSS). IF A SERIOUS ADVERSE EVENT WAS IDENTIFIED THE RESPECTIVE CENTER WAS CONTACTED AGAIN AND FURTHER QUESTIONS RELATED TO THE ADVERSE EVENT WERE ASKED IN DETAIL, E.G. DIAGNOSIS, CLINICAL SEVERITY, TREATMENT, ULTIMATE OUTCOME OF THE EVENT OR DETAILS OF ANATOMIC DISTRIBUTION OF GAS IN PATIENTS WITH LUMINAL PERFORATION. AMONG THE 17067 PATIENTS, 13 HAD A POTENTIALLY SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE. NINE LUMINAL PERFORATIONS WERE DETECTED (FOUR ASYMPTOMATIC, FIVE SYMPTOMATIC). IN FIVE OF THE NINE PATIENTS THE PERFORATION HAD AN ATTRIBUTABLE CAUSE (E.G. FORCIBLE INSERTION OF CATHETER, ULCERATIVE COLITIS, COLONIC CANCER ETC.). A PATIENT OF UNSPECIFIED DEMOGRAPHY (PATIENT (B)(6)) UNDERWENT A CT COLONOGRAPHY WITH A RETENTION BALLOON CATHETER AND AN AUTOMATED CO2 INSUFFLATION DEVICE. THE PROCEDURE WAS COMPLICATED BY CECUM PERFORATION THAT WAS ASYMPTOMATIC. THE CO2 WAS DISTRIBUTED INTRAPERITONEALLY. BETWEEN SIX HOURS AND FOUR DAYS AFTER THE PROCEDURE THE RADIOLOGIST INCIDENTALLY DISCOVERED EXTRA-LUMINAL GAS ASSOCIATED WITH LUMINAL PERFORATION. THE EXACT SITE OF THE PERFORATION WAS DIFFICULT TO ESTABLISH, BECAUSE NO OBVIOUS CAUSE OF THE PERFORATION WAS ATTRIBUTED. THE PATIENT WAS ENTIRELY ASYMPTOMATIC, HAD ALREADY RETURNED HOME AND FELT WELL. THE PATIENT WAS SUBSEQUENTLY CONTACTED AND TREATED AT HOME CONSERVATIVELY. THE PATIENT WAS ALIVE AND DOING WELL AT THE TIME OF THE SURVEY. THE REPORTER CONSIDERED THE EVENT AS POTENTIALLY SERIOUS. DISCUSSION: CT COLONOGRAPHY IS EXQUISITELY SENSITIVE FOR EXTRA-LUMINAL GAS, THEREFORE EVEN ASYMPTOMATIC PERFORATIONS CAN BE DETECTED. THE AUTOMATED DEVICE ALLOWS RECTAL PRESSURE TO BE MONITORED AND INSUFFLATION IS CEASED IF RECTAL PRESSURE INCREASES TO MORE THAN 25 MMHG. THE PERFORATION OCCURRED IN THE CECUM WHICH IS THE COLONIC SEGMENT MOST PRONE TO PERFORATION. THE AUTHOR THEREFORE SUGGESTS THAT FURTHER RESEARCH FOR QUANTIFICATION OF THE INTRALUMINAL PRESSURES GENERATED BY AUTOMATED INSUFFLATION DEVICES IN DIFFERENT COLONIC SEGMENTS SHOULD BE UNDERTAKEN. OUTCOME: RESOLVED THIS CASE IS MEDICALLY CLOSED AS OBTAINING ADDITIONAL DETAILS DOES NOT SEEM TO BE FEASIBLE. CORRECTIVE TREATMENT: CONSERVATIVE TREATMENT AT HOME. CITATION: BURLING D, HALLIGAN S, SLATER A, NOAKES MJ, TAYLOR SA: POTENTIALLY SERIOUS ADVERSE EVENTS AT CT COLONOGRAPHY IN SYMPTOMATIC PATIENTS: NATIONAL SURVEY OF THE UNITED KINGDOM. RADIOLOGY: VOLUME 239 NO. 2 - MAY 2006: 464-471. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173311 EZEM PROTOCOL CO2 L COLON INSUFFLATOR UNIT COLON INSUFFLATOR FCX BRACCO UK LTD. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other