BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOCO2L INSUFFLATION SYSTEM

    MDR report key: 3231929 · Received July 11, 2013

    Report

    Report Number
    2411512-2013-00012
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    September 12, 2012
    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)(6) 2013: THE REPORTER AT THE USER FACILITY REQUESTED PREVENTATIVE MAINTENANCE OF THE DEVICE AND REPORTED TO OCCURRENCES OF PERFORATION. NO MALFUNCTION OF THE DEVICE OR OVER PRESSURE OCCURRENCE 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 BE 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 UNITED AUTOMATICALLY RETURNS TO THE STOP MODE. THEREAFTER TO RESUME THE DELIVERY OF CO2 THE DEVICE OPERATOR PRESS 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 07/05/2013. BRACCO IS CONDUCTING AN INVESTIGATION. THE INVESTIGATION RESULTS ARE NOT YET AVAILABLE. CURRENTLY, THE REPORTING USER FACILITY STAFF HAS NOT PROVIDED DETAILS OF THE PT'S TREATMENT FOR THE MICROPERFORATION OR OUTCOME. ADDITIONAL INFO IS REQUIRED. COMPANY COMMENTS: A (B)(6) MALE PRE-MEDICATED WITH BUSCOPAN (BUTYLSCOPOLAMINE) UNDERWENT A VIRTUAL COLONOSCOPY FOR SCANNING USING THE PROTOCO2L INSUFFLATION SYSTEM AFTER BOWEL CLEANSING WITH MAGNESIUM CITRATE. A TOTAL OF 6.8 LITERS OF CO2 WITH A CONSTANT PRESSURE BETWEEN 20 TO 23 MMHG WAS ADMINISTERED. TEN MINUTES AFTER THE PROCEDURE. A PERFORATION WAS DETECTED BY THE RADIOLOGIST IN THE IMAGES AS SMALL AMOUNT OF FREE AIR IN THE FAT ADJACENT TO THE COLON, ESPECIALLY ON THE LEFT, WITH MINOR RETRO-PNEUMO-PERITONEUM AND MINOR PNEUMO-PERITONEUM, HOWEVER THE PT WAS ASYMPTOMATIC. THE PT WAS TRANSFERRED TO HOSPITAL AND WAS SEEN BY A SURGEON. IN THIS CASE, LOCATION OF PERFORATION, TREATMENT, HOSPITALIZATION AND OUTCOME ARE NOT PROVIDED. DIAGNOSTIC COLONOSCOPY HAS A RISK OF PERFORATION DUE TO MECHANICAL INJURY VIA CATHETER OR DUE TO BAROTRAUMA OR USER ERROR. ADDITIONALLY, RISK OF PERFORATION IS POSITIVELY ASSOCIATED WITH INCREASING AGE BECAUSE OF DECLINING COLONIC WALL MECHANICAL STRENGTH WHICH IS PARTLY DUE TO CHANGES IN THE COLLAGEN STRUCTURE WITH AGE. SMALL PERFORATIONS OFTEN SEAL THEMSELVES OFF, OR MAY ONLY REQUIRE A FEW DAYS IN THE HOSPITAL WITH CLOSE OBSERVATION. THIS PT WAS PRE-MEDICATED WITH BUSCOPAN AND CO2 PRESSURE USED DURING THE PROCEDURE DID NOT EXCEED THE RECOMMENDED PRESSURE. HE HAD NO CLINICAL SYMPTOMS, HE WAS HEMODYNAMICALLY STABLE AND NO IMMEDIATE TREATMENT WAS REQUIRED. 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

    THIS IS THE FIRST OF TWO REPORTS INVOLVING THE SAME DEVICE AT THE SAME USER FACILITY. ON (B)(6) 2013, A HEALTH PROFESSIONAL FROM THE USER FACILITY PROVIDED THE FOLLOWING INFO. A (B)(6) PT UNDERWENT A VIRTUAL COLONOSCOPY FOR SCREENING USING THE PROTOCO2L INSUFFLATION SYSTEM AND EXPERIENCED A MICROPERFORATION. THE PT HAD "NO PARTICULAR MEDICAL HISTORY". HE HAD NEVER HAD INTESTINAL SURGERY. IT WAS UNK IF HE HAD EVER HAD A PREVIOUS COLONOSCOPY. 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 (BUTYLSCOPOLAMINE) 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 23 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 2 MINUTES AND THE TUBING IS DISCONNECTED FROM THE INSUFFLATOR ONCE AGAIN. THE COLONOSCOPY PROCEDURE WAS PERFORMED BETWEEN 9:30 TO 10:00 ON (B)(6) 2012. THE STANDARD TECHNIQUE USED BY THE USER FACILITY WAS FOLLOWED. NO POLYPECTOMY OR BIOPSY WAS PERFORMED. A TOTAL OF 6.8 LITERS OF CO2 WITH A CONSTANT PRESSURE BETWEEN 20 TO 23 MMHG WAS DISPENSED. THE PT HAD NO SYMPTOMS OF PERFORATION SUCH AS PAIN OR DISCOMFORT. THE PERFORATION WAS NOT DETECTED DURING THE PROCEDURE. THE PERFORATION WAS DETECTED TEN MINUTES AFTER THE PROCEDURE WHEN THE RADIOLOGIST WAS READING THE IMAGES WHICH SHOWED AIR BUBBLES ON THE IMAGES. BECAUSE THE PERFORATION WAS DETECTED POST-EXAMINATION AND THE CO2 INSUFFLATION VOLUME WAS 6.8 LITTERS AND CO2 INSUFFLATION WAS NOT INTERRUPTED. THE PERFORATION OCCURRED DURING THE PROCEDURE ON (B)(6) 2012 BETWEEN 9:00 AM AND 10:00 AM. THE PT WAS TRANSFERRED TO HOSPITAL AND WAS SEEN BY A SURGEON. THE REPORTER DOES NOT KNOW IF THE PT RECEIVED ANY TREATMENT OR HAS HOSPITALIZED. THE REPORTER RECEIVED NO FEEDBACK FROM THE SURGEON. THE MEDICAL RECORD FOR THE PROCEDURE AT THE IMAGING FACILITY WAS PROVIDED BY THE REPORTER AND CONTAINED THE FOLLOWING INFO: VIRTUAL COLONOSCOPY BY COMPUTERIZED AXIAL TOMOGRAPHY. CLINICAL INFO: SCREENING BECAUSE OF IODINE ALLERGY. NO IODINE CONTRAST USED. INTERPRETATION: USUAL PROCEDURE, BUSCOPAN IV 20 MG INJECTION WAS PERFORMED. MAGNESIUM CITRATE BOWEL PREPARATION. IMMEDIATELY AFTER EXAMINATION, DOCTOR (NAME WITHHELD BY BRACCO FOR PRIVACY) NOTICED SIGNS OF MICROPERFORATION WITH A SMALL AMOUNT OF FREE AIR IN THE FAT ADJACENT TO THE COLON, ESPECIALLY ON THE LEFT, WITH MINOR RETROPNEUMOPERITONEUM AND MINOR PNEUMOPERITONEUM. THE PT WAS ASYMPTOMATIC. A TRANSFER WAS ORGANIZED TO (NAME OF FACILITY WITHOUT HELD BY BRACCO FOR PRIVACY) SURGERY DEPARTMENT, UNDER THE CARE OF DOCTOR (NAME WITHHELD BY BRACCO FOR PRIVACY). EXCELLENT INTESTINAL PREPARATION. ADEQUATE DISTENSION OF ALL COLIC SEGMENTS. THE CECAL FLOOR IS LOCATED APPROXIMATELY 198 CENTIMETERS FROM THE ANAL VERGE. NO SIGNIFICANT SIZE POLYP OR FURTHER SUSPICIOUS COLIC LESION. INCIDENTALLY, RARE DIVERTICULA IN THE SIGMOID COLON. SMALL SLIDING HIATAL HERNIA. A FEW NON-OBSTRUCTIVE BILATERAL 1-MILLIMETER NEPHROLITHIASES. MODERATE AORTIC ATHEROMATOSIS. NO FURTHER SIGNIFICANT ABDOMINOPELVIC ABNORMALITIES, BASED ON THE LIMITED ASSESSMENT PERFORMED AT LOW-DOSE AND WITHOUT CONTRAST. CONCLUSIONS: THE EXAMINATION WAS COMPLETED BY AN ASYMPTOMATIC MICROPERFORATION FOR WHICH THE PATIENT WAS REFERRED FOR SURGERY. NORMAL VIRTUAL COLONOSCOPY, WITH NO SIGNIFICANT SIZE POLYP OR FURTHER SUSPICIOUS COLIC LESION. NEXT SCREENING SUGGESTED IN 5 YEARS, UNLESS THERE IS A SPECIFIC RISK FACTOR REQUIRING MORE FREQUENT MONITORING. ALSO, A FEW MINOR OBSERVATIONS (SEE DESCRIPTION). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321245 PROTOCO2L INSUFFLATION SYSTEM INSUFFLATOR, AUTOMATIC CARBON DIOXIDE FOR VIRTUAL COLONOSCOPY FCX E-Z-EM, INC. 6400 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR CITROMAG PREPARATION (MAGNESIUM CITRATE)| PROTOCOL2L VC ADMINISTRATION SET| BUSCOPAN (BUTYLSCOPOLAMINE