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	11/17/2017
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: during an rfa procedure, one of the tines of the probe detached.The detachment occurred outside of the patient.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 a starburst talon probe.A visual review of the device noted that the trocar is not adhered to the nose cone preventing the tines from deploying.The handle was opened to visualize the internal assembly.Evidence of adhesive was noted around the nose cone, where the trocar should be glued in place.The trocar was removed and tine #3 was noted to be heavily damaged.The drive tube/array bond was broken in order to remove the damaged tine.Upon removal, a fractured piece of the tine was released.The customer's reported complaint description of a tine breaking off is confirmed.The fractured piece of tine was located within the drive tube after disassembling the device.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/or break off completely.Though this cannot be definitively determined, this event does not appear to be result of any manufacturing anomalies.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.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: STARBURST¿ TALON ELECTRODE
• Common Device Name: ELECTROSURGICAL PROBE,
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7068003
• Report Number: 1056436-2017-00128
• Device Sequence Number: 16471600
• Product Code: GEI
• UDI-Device Identifier: H7877001028471
• UDI-Public: H7877001028471
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K010060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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 Catalogue Number: H7877001028471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1