MAUDE Adverse Event Report: CONMED CORPORATION CLEARTRACE 2 CONDUCTIVE ADHESIVE GEL ADULT ECG ELECTRODE; CLEARTRACE ECG ELECTRODE

Catalog Number 2700-030

Device Problem Overheating of Device (1437)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 12/23/2013

Event Type  Injury  

Event Description

It was reported, "ecg electrode burn to right shoulder during mri scan.It is a 3rd degree burn.The patient received a skin graft from her thigh and is still being seen by plastics.".

Manufacturer Narrative

The devices involved in the reported incident have been discarded by the end-user facility.A supplemental report will be filed on completion of the quality engineering evaluation.Discarded by end-user.

Manufacturer Narrative

The device in question, catalog number 2700-030, is a cleartrace 2 conductive adhesive gel adult ecg electrode provided in a bulk pouch of 30 electrodes.This device is an electrocardiograph electrode, an electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor via lead wires and cables that produce an electrocardiogram to be used by the clinician in diagnosing or monitoring a patient's condition.These electrodes are single use, disposable devices that are intended to be used by experienced and trained medical personnel in hospitals, clinics, physician offices and pre-hospital environments.The 2700-030 cleartrace 2 electrodes have a stud on the device comprised of 40% carbon filled abs plastic, plated with silver/silver chloride (ag/agcl) to provide electrical conductivity.This stud is free of any ferromagnetic, iron-containing materials, as well as free of other metallic materials such as aluminum, copper, or brass that can heat up during an mri procedure and cause burns to the patient.This electrode has been tested and is an mri safe device.A review of the dhr/lhr, device history record/lot history record, was not accomplished as the lot number of the device was not made available.The suspect ecg electrode has been discarded by the end-user facility; therefore, a direct evaluation of the device is not possible.The complaint is inconclusive as no product is being returned for examination.A review of complaint history for a twenty-four (24) month period reveals this as an isolated incident for the reported failure mode of a patient burn resultant from an mri radiological examination for all of the cleartrace ecg electrode product line.Photographs of the patient burn have been sent to conmed corporation confirming the event; however, no photographs of the ecg electrodes that caused the event have been produced.Thus, this incident has not been confirmed to have been caused by a conmed manufactured device.In fact, when first reported to conmed corporation by the end-user facility, this was reported as a patient burn from ecg electrodes during an mri procedure; however, the hospital was not sure if the ecg electrode was our product or one from another supplier.The patient that experienced the mri burn under an ecg electrode that occurred during an mri was examined under a siemens aera 1.5t unit.They were put through various mri unit sequences (pd+t2, t1, stir, dwi, fid, mprage, tof angio) and were exposed to the mri environment for approximately 30 minutes.Conmed's ecg electrode products have been tested as mri safe in a testing performed by an independent contractor, (b)(6).The main objectives of this mri safety testing were to determine the presence of magnetic field interactions, artifacts, and, heating for these devices in association with the use of an mri system.These tests were performed using a 1.5 tesla mri system (general electric co., signa system); therefore, results of the tests that were conducted are applicable to all mri systems with static magnetic field strengths of 1.5 tesla or less.The heating of the ecg electrodes during mri was determined by performing an extreme mri experiment with the ecg electrodes applied to a human subject.Temperature recordings were obtained in this experiment using a luxtron 3100 fluoroptic thermometry system previously demonstrated to be mri-compatible and unperturbed at static magnetic field strengths up to 9.0 tesla.This thermometry system has fiber-optic probes that have an accuracy and resolution of +/-0.1degree c.A fiber-optic probe was placed between the volunteer subject's skin and ecg electrode undersurface to record temperatures during mri.Baseline temperatures were recorded at one minute intervals for 5 minutes.Mri was then performed for 30 minutes, with temperatures being recorded at one minute intervals.The highest temperature changes measured for the ecg electrodes ranged from +0.2 to +0.5 degrees c (+0.2 to +0.4 degrees c for tested conmed products).This relative amount of heating is physiologically inconsequential and will not create a hazard or risk to a patient utilizing one of the ecg electrodes tested, and, undergoing an mri procedure under the conditions of the experiment.In summary, it was concluded that there should be no risks to patients undergoing mri procedures using mri systems operating at 1.5 tesla or less when utilizing any of the tested ecg electrodes.This product is supplied to the end-user facilities in bulk pouches of thirty (30) ecg electrodes.I have inquired of the end-user facility on how these devices are stored on the unit that the patient was on that experienced the mri burn.I have inquired as to how the devices are stored immediately prior to patient utilization.I am looking for the possibility of a non-mri compatible ecg electrode getting mixed in with the mri compatible devices due to the need for bulk storage.To date, i have not received an answer to my inquiry.On the united states fda, food and drug administration, website it points out that, even though you may be using electrodes and cables that are approved for use during an mri, a serious burn can still develop if the electrodes aren't in complete contact with the skin surface (that is, if excess hair hasn't been removed or there's an air gap between the electrode and the skin).When there's an air gap, the electrical pathway is broken and heat can build up at the center of the electrode as well as letting the current arc from the electrode to the skin, which can cause burns.Don't let the cables form a loop and keep them off the patient's skin by placing a blanket under them.Http://www.Fda.Gov/cdrh/devicaldevicesafety/tipsarticles/electrodes.Html it is possible that the cleartrace 2 ecg electrode utilized in this reported procedure, even though an mr safe device, may not have been in complete contact with the patient's skin surface which may have contributed to the end result of the patient experiencing the mri related burn under the ecg electrode.The complaint device was discarded by the end-user facility.The complaint investigation has not identified or confirmed any manufacturing defects associated with the suspect device; therefore, corrective action is not recommended at this time.Conmed is considering this complaint closed.

• Brand Name: CLEARTRACE 2 CONDUCTIVE ADHESIVE GEL ADULT ECG ELECTRODE
• Type of Device: CLEARTRACE ECG ELECTRODE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer Contact: stephen casanova, rn, mps ; 525 french road; utica, NY 13502-5994 ; 3156243463
• MDR Report Key: 3833228
• MDR Text Key: 4396954
• Report Number: 1320894-2014-00060
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 2700-030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2014
• 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
• Patient Outcome(s): Required Intervention