MAUDE Adverse Event Report: EZEM PROTOCO2L VC ADMINISTRATION SET FOLEY TIP

Catalog Number 6470

Device Problems Difficult to Insert (1316); Material Rupture (1546); Extrusion (2934)

Patient Problem Abdominal Pain (1685)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

On (b)(6) 2013 (b)(4), a bracco distributor in (b)(6) received info which was forwarded to bracco on (b)(6) 2014.A staff member of a hosp user facility reported; a malfunction with the protoco2l administration set for colon insufflation occurred.On (b)(6) 2014, a female patient (in her 80s) underwent a colonoscopy at a hosp, but the colonoscopy was discontinued due to difficulty inserting the colonoscope.The patient subsequently complained of abdominal pain and was hospitalized for f/u examinations.The next day, on (b)(6) 2014, a ct colonography was performed at another hospital.Pre-treatment for the ct colonography was unk because it was conducted at a different hosp.The reporter stated that it was likely that the pre-treatment was similar to that for a colonoscopy.A protoco21 administration set for colon insufflation (list number 6470 lot number 50684022 (b)(6) 2014 single use device) was used for the procedure.The administration set rectal catheter balloon cuff volume was initially inflated with 25cc.Approx five minutes after the examination started (co2 insufflation), it was found that the patient had anal sphincter laxity compared with other patients.It was also confirmed that gas escaped through the anus.To continue the examination, the balloon volume was increased from 25cc to 35cc by inflating it with an additional 10cc.When the catheter was slightly pulled back to fix the balloon in the anus, it extruded from the anus.As a result the balloon ruptured.The reporter stated that the balloon did not explode, and the patient didn't recognize the rupture.The administration set (catheter) was then exchanged for a new one to complete the ct colonography.The patient returned home.There were no problems with the patient's condition at the time when the problem occurred.A concomitant device, the protoco2l insufflation system, bracco catalogue number 6400 serial number (b)(4), was used in conjunction with protoco21 administration set for colon insufflation for the ct colonoscopy procedure.(b)(4).

Manufacturer Narrative

Company comments: manufacturing narrative-bracco markets 2 device products used together to perform ct colonography.One is the protoco2l colon insufflator system which administers carbon dioxide during ct colonography for colon insufflation.The protoco2l is a concomitant device and no malfunction or problem was reported with its use.The reporter said the volume of co2 administered was between 1.5 to 2.0 liters and the pressure was 19 mmhg.The suspect device in this report is for the single use administration set used with the protoc2l insufflator.The set has a connector at one end which is inserted into the gas output of the protoco21 colon insufflator system.The other end of the administration set has a silicone rectal catheter with a balloon cuff for insertion into the patient's rectum.Co2 gas is delivered from the protoco2l insufflation system through the administration set to the patient's colon.The administration set also includes a syringe for inflating the balloon cuff.The package insert labeling includes an instruction to lubricate the catheter and retention cuff prior to insertion into the rectum and to inflate the balloon to 30cc using the provided syringe.For this procedure, the catheter cuff was inflated to 35cc.The balloon cuff ruptured during the procedure; however, there was no harm to the patient.A quality investigation is ongoing to determine the cause for this device failure.Company comment: the reported event describes a failure of the device during patient use.There was no adverse event of harm to this patient resulting from this failure.Additionally the labeling for the retention cuff states in capital lettering do not inflate the cuff with more than 30cc of air.Based on the above, even though the event did not cause patient harm and the cuff was over inflated according to instructions, we decided to take a conservative approach and to report this case.

• Brand Name: PROTOCO2L VC ADMINISTRATION SET FOLEY TIP
• Type of Device: PROTOCO2L VC ADMINISTRATION SET FOLEY TIP
• Manufacturer (Section D): EZEM; 532 broadhollow rd, ste 126; melville NY 11747
• Manufacturer (Section G): EZEM; 532 broadhollow rd; melville NY 11747
• Manufacturer Contact: 259 prospect plains rd, bld. h.; monroe twp., NJ 08831 ; 8002575181
• MDR Report Key: 4305710
• MDR Text Key: 5058153
• Report Number: 2411512-2014-00012
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• PMA/PMN Number: K030854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 6470
• Device Lot Number: 50684022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROTOCO2L INSUFFLATION SYSTEM