MAUDE Adverse Event Report: ANGIODYNAMICS THERMOPAD; RF PAD

Catalog Number	H7877001026490
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Date of Event	08/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation into the root cause of this incident is currently in progress.The results of the investigation and any follow up information will be sent via a follow up medwatch.(b)(4) device is not available for return.
Event or Problem Description
As reported on (b)(6) 2016 by angiodynamics territory manager os, " skin burn in the area where one of the rfa pads was placed.Burn is on the inner thigh (anterior) 5" long towards the patient's knee and 2" wide lateral to medial.".
Additional Manufacturer Narrative
This medwatch is not to report a device malfunction, but to report an adverse patient effect.There was no report of a device malfunction or patient complication during the procedure.As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of pad burns could not be confirmed because no sample or photographic evidence was provided.Angiodynamics' supplier of the thermo pads was notified of this event via (b)(4).As the sample was not returned and the lot number was not provided by the user, the supplier was unable to provide a device evaluation or device history review.As stated in the ifu, there is a risk of pad burns when using any electrosurgical device.With a monopolar device this risk will always exist.Although the complaint cannot be confirmed, the most likely cause to this complaint is due to pad burns being an anticipated procedural risk.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications 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: 5933334
• Report Number: 1056436-2016-00040
• Device Sequence Number: 18992178
• Product Code: GEI
• UDI-Device Identifier: H7877001026490
• UDI-Public: H7877001026490
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K031926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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 Catalogue Number: H7877001026490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 06/21/2017
• 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