MAUDE Adverse Event Report: ANGIODYNAMICS THERMOPAD; RF PAD

Catalog Number	H7877001026490
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Codes	Skin Irritation (2076); Burn, Thermal (2530)
Date of Event	06/15/2016
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.A sample is expected to be received.Complaint# (b)(4).
Event or Problem Description
As reported on (b)(6) 2016 by international territory manager, patient received skin burns post-procedure.No further information received so assuming patient was okay and customer continued to us the rfa equipment(different lot number of thermopads).
Additional Manufacturer Narrative
The customer's reported complaint description of "patient received skin burns post-procedure" is confirmed.The dispersive pads are a finished purchased device supplied to angiodynamics by (b)(4).(b)(4) and the returned device were forwarded to (b)(4) for evaluation, root cause determination and a corrective action.Per (b)(4) results from (b)(4), no containment is warranted.All inventory for this lot and raw materials/ subcomponents used in the production of lot# y011615-17 have been shipped to the customer or have been exhausted.A review of the dhr production batch records did not reveal any non-conformanaces associated with this issue.Testing of the returned device confirmed that it met device specifications.As stated int he ifu, there is a risk of burns during surgery.This device has a related hardware unit (serial number (b)(4)).Based on the service order (b)(4) (hw unit complaint file), there is no indication the rfa unit malfunctioned.Based on the low frequency, no adverse trends, no issues noted in the lot history review for the packaging and component lots, and adequate process controls in place, no corrective action to be taken by angiodynamics at this time.(b)(4).

• Brand Name: THERMOPAD
• Common Device Name: RF PAD
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 5781726
• Report Number: 1056436-2016-00032
• Device Sequence Number: 10849143
• Product Code: GEI
• UDI-Device Identifier: H7877001026490
• UDI-Public: H7877001026490
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Paramedic
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2016

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: Health Professional
• Device Catalogue Number: H7877001026490
• Device Lot Number: Y011615-17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 11/04/2016
• 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