MAUDE Adverse Event Report: ANGIODYNAMICS THERMOPAD; RF PAD,

Catalog Number	H7877001026490
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint reference # (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2017: this medwatch is not to report a device malfunction, but to report an adverse patient effect.There was no report of a device malfunction during the procedure.The case was an open surgery ablation.The sales rep of the company was informed and called for the case as an emergency need.The dispersive electrodes were placed by the operation room technician as the patient was under anesthesia and covered by sterile drapes.The sales rep didn't have the chance to check the correct placement of the dispersive electrodes.During the preparation, the operation room staff observed that 2 out of 4 infusion lines of the talon applicator didn't infuse saline.The applicator was changed with a same type of talon.During preparation with the new talon probe, it was observed that the temperature sensors of dispersive electrodes didn't work properly.The temperature sensor cable was disconnected and the maximum power was set up to 150watts.After the second ablation cycle on the second device, 2 out of 4 infusion lines of the applicator didn't infuse saline.The case was finished by this device without proper saline infusion.After the case, a severe skin & tissue burn was observed on the right leg in the area where the dispersive electrodes were placed by the operation room staff.The sales rep and the company were informed about the complication later on.It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The initial medwatch submitted on october 11, 2017 for this complaint was for a starburst talon probe.However, additional information obtained since the submission of the initial medwatch, determined that the patient's burns were caused by the thermal pads used in association with the probe during the rfa procedure.This follow up medwatch has been amended with the new information.As the reported device was not returned, angiodynamics is unable to perform a device evaluation.A device evaluation could not be performed, therefore, a definitive root cause cannot be determined.The customer's report of patient burn is confirmed based on the report.A definitive root cause for this event cannot be determined, however it does not appear to be manufacturing related.Based on information provided in the clinical review, the most likely root cause to this event is due to the pads being placed in an incorrect location and then overriding of the alarm.A review of the hardware service records for the account's rf generator (sn (b)(4)) noted no servicing, repairs or upgrades since july 2014.A review of the lot history records of the disposable thermal pads (obtained through the ship history report) was performed for the packaging and component lots for any deviations.A device history records search revealed no quality related issues or manufacturing deficiencies.The instruction for use which is supplied to the user with this catalog number, contains the following statements: improper placement of the dispersive electrodes may result in a skin burn or poor electrical performance of the system avoid pad placement over scars, bony prominences, metal prostheses, or ecg electrodes.Avoid placement of a metal object (i.E.A metal prosthesis) in the path between the active electrode and the dispersive electrodes as it could heat up.Avoid placement in areas where liquid may pool.Patients with peripheral vascular deficiency are at increased risk of thermal injury from dispersive electrodes.Patients with frail skin are at increased risk of skin damage from the adhesive on the dispersive pads.Pediatric or geriatric patients may be at an increased risk of pad burns.Precautions: if a portion of the pad wraps around to the posterior of the leg (and patient is supine) it is recommended that the patient's knees be elevated to eliminate pressure on the pad and to allow for cooling (air flow) at the pad site.It is also recommended to avoid skin-to-skin or pad-to-pad contact, such as between the legs or between the torso and arms, by insulating with sheets or another dry material.Low power output or failure of the equipment to function correctly at normal setting may indicate faulty application of the dispersive electrode or failure of an electrical lead.Do not increase power output before checking for obvious defect and application.If the patient is repositioned during the procedure, reinspect the dispersive electrodes and all connections.Heat applied by thermal blankets or other sources is cumulative with heat produced under the dispersive electrode.Placing heat sources away from the location of the dispersive electrodes may minimize risk of skin burn.Any application or procedure that alters tissue perfusion and affects temperature elevation should be monitored carefully.If a bair hugger(r) or another warming device is used, turn it off prior to the ablation as this may constrict blood flow and elevate the temperature.If leg/circulation compressors are used, use calf-length devices, so that there is no overlap with the dispersive electrodes.The risk of burn increases when the ablation site requires the placement of the dispersive electrodes on locations other than that recommended for the liver.When performing an rf ablation therapy it is essential that the edges of the dispersive electrodes are frequently checked for hot spots, and if found the procedure stopped and the dispersive electrodes replaced with new ones and moved to different locations on the body before continuing.Apply ice pack or chemical cool pack uniformly across the entire leading edge (edge opposite cable connection) of the dispersive electrodes when attempting to lower the temperature of the pads.Partially cooling the leading edge of the pad may result in a pad burn.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint reference (b)(4).

• Brand Name: THERMOPAD
• Common Device Name: RF PAD,
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6935057
• Report Number: 1056436-2017-00106
• Device Sequence Number: 1183199
• Product Code: GEI
• UDI-Device Identifier: H7877001028471
• UDI-Public: H7877001028471
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K031926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: H7877001026490
• Device Lot Number: 5179240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention