MAUDE Adverse Event Report: ANGIODYNAMICS TALON 15CM SEMIFLEX; ELECTROSURGICAL PROBE

Catalog Number	H7877001028471
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem 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) 2017: it found that probes could not be deployed for withdrawing 3cm back for re-ablation, after one complete ablation.Connection mistake was displayed on generator,pull out the electrode, and found one of probe tip was broken.Tip did not break off inside of the patient, patient did not suffer any harm or injury.It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one talon probe.A visual review noted the presence of dried saline.Array #1 is broken off halfway.The remaining arrays appear in good condition.Array window #1 was viewed under a microscope and the tine tip is visualized to be stuck under the edge of the window.A portion of the thermocouple wires can be seen inside the tine.The customer's reported complaint description of a tine breaking off is confirmed.The fractured off piece of tine was visualized trapped in the deployment window.This event occurred outside the body and the patient was unaffected.The most likely root cause of the arrays being broken is due to twisting or excessive force during use.The ifu states that 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.It's possible to damage/weaken the tine if it becomes caught in the ablated tissue and it is not freed gently.If this did occur unnoticed, and an attempt was made to re-deploy for the next ablation, the tine can become trapped in the deployment window and break off completely.Though this cannot be definitively determined, this event does not appear to be result of any manufacturing anomalies.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.This device is fully deployed in the device tray when shipped from the manufacturing facility.The instruction for use, which is supplied to the user with this catalog number, contains the following statements: inspect the device for any damage.Do not use a device that has been damaged.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.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." 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: TALON 15CM SEMIFLEX
• Common Device Name: ELECTROSURGICAL PROBE
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6833583
• Report Number: 1056436-2017-00101
• Device Sequence Number: 18849015
• Product Code: GEI
• UDI-Device Identifier: H7877001028451
• UDI-Public: H7877001028451
• 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): 11/16/2017

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: 03/31/2019
• Device Catalogue Number: H7877001028471
• Device Lot Number: 5008789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1