MAUDE Adverse Event Report: ANGIODYNAMICS STARBURST¿ TALON ELECTRODE; ELECTROSURGICAL PROBE

Catalog Number	H7877001028471
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6), 2018.One tine was broken during procedure.No any adverse further feedback on patient.The reported defective device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a talon probe.A visual review of the device noted it appears used.All 4 tines are fractured off.When viewed under a microscope, tine #1 appears to be stuck in the deployment window.The fractured off tines #2, 3 and 4 could not be found within the windows.The customer's reported complaint description of a tine breaking off (tip fractured) is confirmed.Although the complaint description states only one tine was broken, the sample confirms all the tines are broken.This device is fully deployed in the device tray when shipped from the manufacturing facility.Though it cannot be definitively determined, the most likely root cause to this event is due to handling.The ifu states "if retraction of the device becomes difficult, do not exert additional force.Infuse a small amount of saline solution and gently work the needles loose by alternating between a slightly retracted and a deployed position (while holding the main body with one hand and the trocar (at the point of insertion) with the other hand).The saline solution will generally soften the ablated tissue surrounding the electrodes" a device history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.This does not appear to be the result of a manufacturing failure.The instruction for use), which is supplied to the user with this catalog number, contains the following statements: "do not attach anything (i.E., clamps, etc.) to the device.This may damage the insulation, which could contribute to patient injury.Do not twist or exert high forces on the device while it is deployed in the tissue.This may cause the needles to break and remain in the tissue.Do not remove the device without ensuring that the needles are fully retracted within the trocar.This may cause the needles to break and remain in the tissue.Do not bend or kink the trocar or the needles.This may cause damage and result in a non-functional device.If retraction of the device becomes difficult, do not exert additional force.Infuse a small amount of saline solution and gently work the needles loose by alternating between a slightly retracted and a deployed position (while holding the main body with one hand and the trocar (at the point of insertion) with the other hand).The saline solution will generally soften the ablated tissue surrounding the electrodes.Once the ablated tissue softens, the arrays can be worked loose from the tissue and fully retracted.Reprocessing may compromise the integrity of the device and / or lead to device failure.Inspect the device for any damage.Do not use a device that has been damaged.Fully retract the device needles by moving the slide on the handle backward (towards the cable connector) until it stops.Deploy the device needles by moving the slide forward (towards the trocar) on the handle to the desired deployment size.If having difficulty retracting array: consider infusing saline and working shaft back and forth to loosen ablated tissue.Also, cleaning the array by wiping off the tissue with a coarse sponge or gauze in between ablations can help prevent difficulty in retraction.Do not use sharp objects to clean the needles as this can damage them and make the device not function properly." 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: STARBURST¿ TALON ELECTRODE
• Common Device Name: ELECTROSURGICAL PROBE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7569821
• Report Number: 1317056-2018-00094
• Device Sequence Number: 18867992
• Product Code: GEI
• UDI-Device Identifier: H7877001028471
• UDI-Public: H7877001028471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010060
• 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): 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: H7877001028471
• Device Lot Number: 5139966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1