MAUDE Adverse Event Report: BRACCO DIAGNOSTIC INC CO2EFFICIENT ENDOSCOPIC INSUFFLATOR; INSUFFLATOR, CARBON DIOXIDE FOR ENDOSCOPE

Catalog Number 6600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 01/01/2014

Event Type  No Answer Provided  

Event Description

On (b)(6)-2014: a staff member of a user facility provided information to a bracco representative, which was sent to bracco's drug safety department the same day, (b)(6)-2014.The user facility staff member reported: two patients (no patient identifiers were provided), experienced colonic perforation while using the co2efficient insufflator catalogue number 6600 serial number (b)(4).The tube sets (patient administration sets) used with the co2efficient insufflator were medivators 2 piece parts numbers 100551 and 100145co2 (non-bracco devices).The insufflator unit is no longer in use at the facility.No additional details of the perforation occurrences were provided.A bracco representative visited the facility and verified that the co2efficient was working properly and flowing at 3.2 1/min (liters/minute) of co2 gas in the free flow mode of operation (bracco's specification for the device is 2.7 to 3.6 l/min).On the same day (b)(6)-2014, a bracco staff member provided instructions of how to return the co2efficent device to bracco, how to receive a loaner device and requested additional information on the specifics of the perforations.Additional information has not yet been provided.On (b)(6)-2014, the reporting facility staff member provided additional information, which was incorporated into bracco's initial report.The procedure for both patients was a colonoscopy performed on unspecified dates in 2014.The indication for the procedure for both patients was routine screening.The brand of endoscope used was olympus.Both patients were hospitalized due to the perforation and both patients received treatment and recovered.There was no malfunction of the co2efficient that they are aware of and they are returning the device to bracco for investigation.The reporter was asked for additional information but declined to provide additional information due to concerns the legal department at the facility may have.Since, at the time of this report, the facility has not provided any patient identifiers, bracco has established one summary report for these two occurrences.(b)(4).

Manufacturer Narrative

Limited information on the specifics of the patient colonic perforations has been provided and bracco has requested additional information.Arrangements were made for the return of the co2efficient device for evaluation by bracco.Bracco markets specific patient administration tubing set to be used in conjunction with co2efficient insufflator.The co2efficient user manual instructs to only use the bracco administration sets when using the co2efficient.The co2efficient endoscopic insufflator is designed to use co2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.The device operates by administering co2 gas at a maximum flow rate of 3 l/min, and then monitoring the endoscopic pressure.The clinician will use the air/water valve on the endoscope and visual feedback of the endoscopic system to manually direct the co2 gas flow to distend the gastrointestinal tract with co2.Additionally, the co2efficient endoscopic insufflator has two safety pressure relief valves which will relieve pressure when their set point is achieved.An electronically controlled pressure relief valve set at 375 mm hg.An independent redundant mechanical pressure relief valve pre-set to 400 mm hg.Both pressure relief safety valves are active whether the flow stop/run is on or off.Additional information is required.Company comments: this case refers to 2 patients who experienced colonic perforation while using the co2efficient insufflator.Both patients were hospitalized due to the perforation and received unspecified treatments.The 2 patients recovered on an unknown date.The insufficient information provided including but are not limited to complete medical history, relevant labs/diagnostics (including baseline prior to use of co2efficient) and detailed clinical course/circumstances leading to the perforation for the 2 patients precludes a complete and meaningful medical analysis.It was reported that there were no malfunction that occurred with coefficient e;at the reporter was aware of.However despite this and based upon a conservative approach, bracco feels this occurrence is reportable as an mdr.The brand of endoscope used was olympus (part number unspecified) and the tube set used was medivators 2 piece parts numbers 100551 and 100145co2 (a non bracco device).Of note, the co2efficient user manual specifies to use only e-z-em's co2efficient endoscopic insufflator tubing set which includes a =0.2 micron hydrophobic filter.A copy of the fda submission must be sent to bsi.The occurrence is not currently reportable to the (b)(6) health authority because it did not occur in (b)(6) and no corrective action has been taken.A summary file for the two patients has been entered in bracco database and one (b)(4), has been established.A second file and clintrace number will be established if additional information is reported which provides distinguishing information for the two occurrences.Additional information is required.

• Brand Name: CO2EFFICIENT ENDOSCOPIC INSUFFLATOR
• Type of Device: INSUFFLATOR, CARBON DIOXIDE FOR ENDOSCOPE
• Manufacturer (Section D): BRACCO DIAGNOSTIC INC; 532 broadhollow rd; ste# 126; melville NY 11417
• Manufacturer (Section G): EZEM; 532 broadhollow rd; melville NY 11747
• Manufacturer Contact: 259 prospect plains rd; bldg h; monroe twp, NJ 08831 ; 8002575181
• MDR Report Key: 4275352
• MDR Text Key: 5292925
• Report Number: 2411512-2014-00010
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MEDIVATORS
• Patient Outcome(s): Hospitalization