MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC CERTUS 140 2.45 GHZ ABLATION SYSTEM; MICROWAVE ABLATION SYSTEM AND ACCESSORIES

Model Number	PR20
Health Effect - Clinical Codes	Cardiac Arrest (1762); Blood Loss (2597)
Date of Event	06/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunction is alleged.The probe was not returned to neuwave for evaluation and has been discarded by the user.The ablation system logs were reviewed and confirmed the power and time settings for the ablation and the tract cautery of both probes.No probe or system errors occurred during the procedure.A review of the device lot history records for the probes used indicated that the probes met all specifications and passed all manufacturing tests.No additional investigation is planned.Neuwave is attempting to obtain more information about the patient's current status and any follow-up care required.Post-ablation bleeding is a known potential complication of thermal ablation procedures.A follow-up mdr will be submitted if additional information becomes available.
Event or Problem Description
On (b)(6), dr.(b)(6) notified a neuwave territory manager that the female patient that he performed a neuwave renal mwa on (b)(6) had experienced significant internal bleeding 5 hours post ablation, that she had coded and was stabilized in the unit after losing large amounts of blood.The case involved the use of 2 pr 20cm probes.The first involved the use of a 13ga introducer to facilitate probe placement.Both probes were ablated at 65w for 10 minutes to treat a 3.1cm lesion.Upon completing the ablation, the physician performed tract cautery when he removed the probes from the patient.The case was completed without incident.No device malfunction is alleged.

• Brand Name: CERTUS 140 2.45 GHZ ABLATION SYSTEM
• Common Device Name: MICROWAVE ABLATION SYSTEM AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC; 3529 anderson street; madison WI 53704
• MDR Report Key: 6762241
• Report Number: 3008769756-2017-00014
• Device Sequence Number: 1733508
• Product Code: NEY
• UDI-Device Identifier: 00853719006012
• UDI-Public: 00853719006012
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K113237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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: Physician
• Device Expiration Date: 10/01/2020
• Device Model Number: PR20
• Device Catalogue Number: PR20
• Device Lot Number: ML17012578
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 08/02/2017
• 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: Required Intervention
• Patient Age: 50 YR