BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOCO2L INSUFFLATION SYSTEM

    MDR report key: 3231926 · Received July 11, 2013

    Report

    Report Number
    2411512-2013-00013
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 11, 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
    CA
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013: THE REPORTER AT THE USER FACILITY REQUESTED PREVENTATIVE MAINTENANCE OF THE DEVICE AND REPORTED TWO OCCURRENCES OF PERFORATION. NO MALFUNCTION OF THE DEVICE OR OVER PRESSURE SITUATION WAS REPORTED. THE PROTOCO2L DEVICE HAS REDUNDANT PRESSURE RELIEF VALVES TO PROTECT AGAINST OVER PRESSURE OF THE COLON. SPECIFICALLY, AN ELECTRICAL PRESSURE RELIEF VALVE WILL OPEN WHEN A PRESSURE OF 50 MMHG IS REACHED AND SUSTAINED FOR 5 SECONDS, AN AUDIBLE ALARM WILL SOUND AND THE PRESSURE DISPLAY ON THE FRONT PANEL OF THE DEVICE WILL FLASH. A SECOND INDEPENDENT FIXED MECHANICAL PRESSURE RELIEF VALVE OPENS IF A PRESSURE OF 75 MMHG IS REACHED. ADDITIONALLY DURING INITIAL INSUFFLATION WHEN 4 LITERS OF CO2 ARE DELIVERED THE UNIT AUTOMATICALLY RETURNS TO THE STOP MODE. THEREFORE, TO RESUME THE DELIVERY OF CO2, THE DEVICE OPERATOR PRESSES THE FLOW STOP/RUN BUTTON TO DISPENSE AN ADDITIONAL 2 LITERS OF CO2 AND THE UNIT AGAIN AUTOMATICALLY RETURNS TO THE STOP MODE. THE DEVICE WAS RETURNED FROM THE USER FACILITY TO BRACCO ON (B)(4) 2013. BRACCO IS CONDUCTING AN INVESTIGATION. THE INVESTIGATION RESULTS ARE NOT YET AVAILABLE. ADDITIONAL INFO IS REQUIRED. COMPANY COMMENTS: A (B)(6) YEAR OLD MALE PRE-MEDICATED WITH BUSCOPAN (BUTYLSCOPOLAMINE) UNDERWENT A VIRTUAL COLONOSCOPY FOR SCREENING USING THE PROTOCO2L INSUFFLATION SYSTEM AFTER BOWEL CLEANSING WITH MAGNESIUM CITRATE. A TOTAL OF 4.3 LITERS OF CO2 WITH A CONSTANT PRESSURE BETWEEN 20 TO 23 MMHG WAS ADMINISTERED. TEN MINUTES AFTER THE PROCEDURE. A PERFORATION WAS DETECTED WITH FEW AIR BUBBLES ALONG THE COLIC FRAME, HOWEVER, THE PT WAS ASYMPTOMATIC. HE WAS REFERRED TO A SURGEON AND WAS HOSPITALIZED THE SAME DAY FOR THREE DAYS; HE WAS TREATED WITH UNSPECIFIED INTRAVENOUS ANTIBIOTICS FOR EIGHT DAYS. IN THIS CASE, LOCATION OF PERFORATION, TREATMENT DETAILS, AND OUTCOME ARE NOT PROVIDED. THE PT WAS PRE-MEDICATED WITH BUSCOPAN AND CO2 PRESSURE USED DURING THE PROCEDURE DID NOT EXCEED THE RECOMMENDED PRESSURE. DIAGNOSTIC COLONOSCOPY HAS A RISK OF PERFORATION DUE TO MECHANICAL INJURY VIA CATHETER OR DUE TO BAROTRAUMA. ADDITIONALLY, RISK OF PERFORATION IS POSITIVELY ASSOCIATED WITH INCREASING AGE SINCE THE ELDERLY MIGHT HAVE A DECLINING COLONIC WALL MECHANICAL STRENGTH WHICH IS PARTLY DUE TO CHANGES IN THE COLLAGEN STRUCTURE WITH AGE. SMALL PERFORATIONS OFTEN SEAL THEMSELVES OFF, SO THEY MAY ONLY REQUIRE A FEW DAYS IN THE HOSPITAL WITH CLOSE OBSERVATION. HOWEVER, SINCE THERE IS A TEMPORAL ASSOCIATION AND IN THE ABSENCE OF ALTERNATIVE EXPLANATION, CAUSALITY CANNOT BE EXCLUDED. FURTHER INFO IS REQUIRED.

    Description of Event or Problem · 1

    NARRATIVE: THIS IS THE SECOND OF TWO CASES INVOLVING THE SAME DEVICE AT THE (B)(6) USER FACILITY. ON (B)(6) 2013, A HEALTH PROFESSIONAL FROM THE USER FACILITY PROVIDED THE FOLLOWING INFO: A (B)(6) YEAR-OLD MALE PT UNDERWENT A VIRTUAL COLONOSCOPY FOR SCREENING USING THE PROTOCO2L INSUFFLATION SYSTEM AND EXPERIENCED A PERFORATION. IT WAS REPORTED THAT THE PT HAD "NO SPECIAL MEDICAL HISTORY". ISOLATED DIVERTICULUM IN THE SIGMOID COLON WERE NOTED DURING THE PROCEDURE. THE PT HAD NO HISTORY OF ANY INTESTINAL SURGERY. HE HAD UNDERGONE A PREVIOUS VIRTUAL COLONOSCOPY AT THE SAME FACILITY IN 2009. THE PROTOCOL USED FOR COLONOSCOPY AT THE FACILITY WAS DESCRIBED AS FOLLOWS: WE INSERT THE CANNULA IN THE RECTUM. IF THE PT DOES NOT HAVE ANY CONTRAINDICATION, BUSCOPAN IS INJECTED INTRAVENOUSLY. ABOUT 1 LITER OF CO2 IS ADMINISTERED WITH THE PT IN THE RIGHT LATERAL DECUBITUS POSITION AND THEN, WITH THE PT IN THE LEFT LATERAL DECUBITUS POSITION, CO2 IS INSUFFLATED UNTIL A PRESSURE CLOSE TO 20 MMHG IS OBTAINED. WITH THE PT LYING ON HIS BACK, WE TAKE OUR FIRST IMAGES, WITH A CONSTANT PRESSURE BETWEEN 20 TO 20 MMHG. ONCE THE IMAGES ARE TAKEN, THE TUBING IS DISCONNECTED FROM THE INSUFFLATOR. THE PT IS THEN PLACED ON HIS STOMACH AND CO2 INSUFFLATION IS RESUMED UNTIL THE PRESSURE IS CONSTANT BETWEEN 20 TO 23 MMHG. IMAGES ARE TAKEN FOR ABOUT TWO MINUTES AND THE TUBING IS DISCONNECTED FROM THE INSUFFLATOR ONCE AGAIN. THE COLONOSCOPY PROCEDURE WAS PERFORMED BETWEEN 8:30 AM TO 9:00 AM ON (B)(6) 2013. THE INDICATION FOR THE PROCEDURE WAS "MONITORING". THE STANDARD TECHNIQUE USED BY THE USER FACILITY WAS FOLLOWED. NO POLYPECTOMY OR BIOPSY WAS PERFORMED. A TOTAL OF 4.3 LITERS OF CO2 WAS DISPENSED WITH A CONSTANT PRESSURE BETWEEN 20 AND 23 MMHG. THE PT HAD NO SYMPTOMS OF PERFORATION SUCH AS PAIN OR DISCOMFORT. THE PERFORATION WAS NOT DETECTED DURING THE PROCEDURE, BUT TEN MINUTES POST PROCEDURE WHEN THE RADIOLOGIST WAS READING OF THE IMAGES WHICH REVEALED AIR BUBBLES ON THE IMAGES. BECAUSE THE PERFORATION WAS DETECTED POST-EXAMINATION, THE CO2 INSUFFLATION VOLUME WAS 4.3 LITERS AND CO2 INSUFFLATION WAS NOT INTERRUPTED. THE PERFORATION OCCURRED DURING THE PROCEDURE ON (B)(6) 2013, BETWEEN 8:30 AM AND 9:00 AM. THE SITE OF PERFORATION IS UNK. THE PT WAS HOSPITALIZED THE SAME DAY FOR THREE DAYS. UNSPECIFIED INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED FOR EIGHT DAYS. THE MEDICAL RECORD FOR THE PROCEDURE AT THE IMAGING FACILITY WAS PROVIDED BY THE REPORTER AND CONTAINED THE FOLLOWING INFO: VIRTUAL COLONOSCOPY BY COMPUTERIZED TOMOGRAPHY SCAN. STANDARD TECHNIQUE. BUSCOPAN 20 MG INTRAVENOUS INJECTION. CITROMAG BOWEL PREPARATION. THE DISTANCE BETWEEN THE ANAL VERGE AND THE CECAL FLOOR IS APPROXIMATELY 160 CENTIMETERS. ON AXIAL SECTION OBTAINED A LOW KILOVOLTAGE THERE IS NO EVIDENCE OF ACTIVE LESION IN INTRA-ABDOMINAL ORGANS. NO STENOTIC LESION. DEVELOPMENT OF ISOLATED DIVERTICULUM IN SIGMOID COLON WITHOUT PERIDIVERTICULITIS. NO POLYPOID LESION. DURING EXAMINATION, EXTRAVASATION OF SMALL AIR BUBBLES WAS OBSERVED ALONG THE COLIC FRAME THAT IS WHY WE REFERRED THE PT TO A DOCTOR (NAME WITHHELD BY (B)(4) DUE TO PRIVACY) FOR SURGERY, TO PREVENT PERITONITIS. OPINION: NORMAL VIRTUAL COLONOSCOPY, WITH NO SIGNIFICANTLY SIZED POLYP OR FURTHER SUSPICIOUS COLIC LESION. NEXT SCREENING RECOMMENDED IN FIVE YEARS, UNLESS THERE IS A SPECIFIC RISK FACTOR REQUIRING MORE FREQUENT MONITOR. ISOLATED DIVERTICULUM IN SIGMOID COLON. PERFORATION WITH A FEW AIR BUBBLES ALONG COLIC FRAME, WHICH IS WHY PATIENT WAS REFERRED TO DOCTOR (NAME WITHHELD BY (B)(4) DUE TO PRIVACY) FOR SURGERY. WORLDWIDE CASE ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321244 PROTOCO2L INSUFFLATION SYSTEM INSUFFLATOR, AUTOMATIC CARBON DIOXIDE FOR VIRTUAL COLONOSCOPY FCX E-Z-EM, INC. 6400 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization PROTOCO2L VC ADMINISTRATION SET| BUSCOPAN (BUTYLSCOPOLAMINE| CITROMAG PREPARATION (MAGNESIUM CITRATE)