MAUDE Adverse Event Report: EZEM PROTOCOL ADMIN SET; PROTOCOL COLON INSUFFLATOR - 6400

Lot Number 50704075

Device Problem Air Leak (1008)

Patient Problem Perforation (2001)

Event Date 09/18/2014

Event Type  No Answer Provided  

Event Description

Case received from a ct clinical specialist at (b)(6) on (b)(6) 2014 and forwarded to (b)(4)) on the same day.Additional info was obtained from the reporter directly at (b)(4) on (b)(4) 2014.A health professional reports: an (b)(6)-year-old female pt had undergone a colonoscopy on (b)(6) 2014 and the procedure could not be completed beyond 60 cm.Therefore, a ct colonography was performed with protoco2l administration set insufflator (lot number 50704075, serial number (b)(4)) on (b)(6) 2014.While the pt was supine on the table and co2 gas ran out the cylinder was changed and they proceeded with the examination.The pt well tolerated the examination, she did not have any pain and was asymptomatic.On the ct, the radiologist suspected a perforation with free air, however, the location could not be identified.The ct colonography also revealed extensive diverticular disease and looping of the colon which was considered the cause, why the colonoscopy had not been successful.The pt subsequently was admitted to the surgical unit for 6-7 days.The reporter did not consider there was a connection between the non-completed colonoscopy on (b)(6) 2014 and the suspected perforation.The reporter assessed the asymptomatic bowel perforation as related to the underlying diverticular disease.The insufflator was not used after this pt.Outcome: unk.Further info has been requested.(b)(4).

Manufacturer Narrative

Company comments: an (b)(6)-year-old female pt with extensive diverticular disease underwent a colonoscopy for an unk indication.The procedure could not be completed due to both pt's underlying disease and formation of loops in colon during the procedure.Therefore, 12 days after the pt underwent a ct colonoscopy with protoco2l.During the ct following co2 insufflation, free air outside of the colon was seen leading to the diagnosis of suspected bowel perforation.No info on total amount of gas, maximum pressure used during the procedure and duration on the procedure is available.As the pt had no clinical symptoms neither during the examination nor subsequently to this investigation, the clinical picture is unlikely for a serious bowel perforation he event was assessed as pt related by the reporter.Bracco agrees that the extensive diverticular disease in this elderly pt could have favored this event.

• Brand Name: PROTOCOL ADMIN SET
• Type of Device: PROTOCOL COLON INSUFFLATOR - 6400
• Manufacturer (Section D): EZEM; 532 broadhollow rd; melville NY 11747
• Manufacturer (Section G): EZEM; 532 broadhollow rd; melville NY 11747
• Manufacturer Contact: 259 prospect plains rd; bldg h; monro twp, NJ 08831 ; 8002575181
• MDR Report Key: 4202121
• MDR Text Key: 5037115
• Report Number: 2411512-2014-00009
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K030854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 50704075
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR