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

Catalog Number	700102845
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Second device: a clinical specialist reported an end user experienced an issue when using a talon 25cm semiflex.The cs received a call from the ir tech regarding an issue with two rita starburst rfa probes.After the initial prep of device one where the infusion tubing was pulled into the infusion pump, ((b)(6)), they switched it our for a second probe.Upon opening the second device it was attached and the infusion tubing put into place.Upon priming saline began to "squirt" from the tubing from the little white disc on the side of the tubing where the white separation tab is.The complainant stated it was broken upon opening.He also stated he tried to fix it back onto the tubing but at priming again spewed saline.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.Additional information reported the patient was under general anesthesia and the case was delayed approximately 45 minutes to 1 hour.This event meets the criteria a reportable adverse event; patient safety risk due to prolonged procedure greater than 30 minutes (extended sedation).
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).1st device: (b)(4), 1317056-2023-00128.2nd device: (b)(4), 1317056-2023-00129.
Additional Manufacturer Narrative
Returned for evaluation was one (1) semiflex 25cm talon probe.As received, the tubing with the transducer was broken off the manifold.Product engineer evaluation: found the tubing with the transducer was broken and leaking fluid.Additionally found 3 of the 4 other tubing broken from the manifold and tubing disconnected from the holder.Likely due to improper placement in pump.After assembly tubing sets are tested for leak and flow.This defect would be caught during this testing if it was present at this time.No corrective action at this time for tubing handling issue, unable to determine when the damage was caused.The customer's complaint description is confirmed for tubing broken off of the manifold fittings.The root cause of the broken tubing is likely due handling damage, however, when this damage occurred cannot be definitively determined.A review of the device history records was performed for the indicated lot for any deviations related to the reported failure mode of the complaint.The review confirms that the lot met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use, which is supplied to the user with the solero applicators contains the following statements; "inspect all devices and packaging for damage prior to use.Do not use any devices that are damaged or if the sterile barrier is breached."the solero microwave tissue ablation (mta) system and accessories are indicated for the ablation of soft tissue during open procedures.Avoid placing lateral forces on the applicator tip during placement or removal.Always use the lowest power and shortest time necessary to achieve the targeted ablation.Inspect the applicator after each ablation.If the applicator appears damaged, utilize another applicator for subsequent ablations.Warning: when placing the device, use the minimum force necessary and take care not to over advance the applicator.Refer to the shaft depth markings to monitor placement depth.Take care to not bend the tip as it may cause damage to the device.Do not energize the applicator unless the active region of the applicator is fully inserted into target tissue.If the applicator is not properly located into the selected tissue, an unintended thermal injury may occur.After each ablation inspect the applicator for any damage.If any damage is observed the applicator should be discarded and replaced with a new applicator." 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.Reference (b)(4).1st device: (b)(4), 1317056-2023-00128.2nd device: (b)(4), 1317056-2023-00129.

• Brand Name: STARBURST¿ TALON ELECTRODE
• Common Device Name: ELECTROSURGICAL PROBE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17765986
• Report Number: 1317056-2023-00129
• Device Sequence Number: 7093806
• Product Code: GEI
• UDI-Device Identifier: H7877001028451
• UDI-Public: H7877001028451
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 700102845
• Device Lot Number: 5751616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown