MAUDE Adverse Event Report: ANGIODYNAMICS 15 CM IRE SINGLE ELECTRODE; LOW ENERGY DIRECT CURRENT ABLATION SYSTEM

Model Number	20400107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The associated device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.This medwatch is not to report a device malfunction, but to report an adverse patient effect post procedure.There was no report of a device malfunction or patient complication during the procedure.Reference (b)(4).
Event or Problem Description
An interventional radiologist reported the following incident, post ire/ nanoknife procedure, to an angiodynamics territory manager: "i was called on 05/11/21 by dr.(b)(6) regarding a patient treated on (b)(6) 2021 surgically in the or at uf shands in (b)(6).It is my understanding that the patient received a pancreatic resection, with ire/nanoknife and is enrolled in the registry of the direct trial.On the evening of (b)(6) 2021 dr.(b)(6) called me to notify me that the patient had experience complications due to the surgery and the family had chosen to transition the patient to comfort care or hospice rather than seek additional interventions.Dr.(b)(6) let me know that the patient was still alive but was expected to pass away in the coming days.Dr.Heithaus also stated that the cause of the complication was undetermined.It is not known if it was a complication related to the surgical procedure, resection, or ire portion of the surgery.I spoke with dr.(b)(6) on the morning of (b)(6) 2021 to check on the patient status and he had no update at the time." additional information received on may 13, 2021, reported the patient had not expired as of yet.It was reported by the physician, that the patient complications were related to an infection that had developed a week or more out from surgery, during which time the patient ignored their symptoms.There was no suspicion or allegation that the nanoknife system contributed to or caused the patient issue.It was indicated that the associated device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
It is being tracked and reported through the direct ide trial associated with patient # (b)(4) of the direct ide trial study.This event will be adjudicated by the clinical endpoints committee (cec) at a later date to determine relationship with ide.This report is being submitted to close out the compalint file.Reference (b)(4).
Event or Problem Description
This complaint file is being canceled as it is being tracked and reported through the direct ide trial associated with patient # (b)(6) of the direct ide trial study.This event will be adjudicated by the clinical endpoints committee (cec) at a later date to determine relationship with ide.

• Brand Name: 15 CM IRE SINGLE ELECTRODE
• Common Device Name: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11900018
• Report Number: 1317056-2021-00111
• Device Sequence Number: 19754862
• Product Code: OAB
• UDI-Device Identifier: H787204001070
• UDI-Public: H787204001070
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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 Model Number: 20400107
• Device Catalogue Number: 20400107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 06/18/2021
• 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: Other
• Patient Age: 67 YR