MAUDE Adverse Event Report: ENDOCARE INC. MICROTHERMX MICROWAVE ABLATION SYSTEM; MICROWAVE ABLATION SYSTEM AND ACCESSORIES

Model Number	SWST-1420
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiopulmonary Arrest (1765)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following resolution of the cardiac event, by the anesthesia md and crna, the patient was stabilized and the procedure continued as normal.The disposable device was discarded by the user and is not available for evaluation.Investigation into the relationship between the procedure and the cardiac event is currently in progress.Device history record review is also in progress.The results of the investigation and device history record review will be sent via a follow up report.
Event or Problem Description
(b)(6) clinical education specialist reported that upon arrival at the hospital, mtx generator was safety checked by biomed.Patient was placed on ct scanner and anesthesia was administered.Initial ct scans were obtained and mtx probe was placed.45 seconds into the burn, patient went into asystole.Crna and anesthesia md assessed, gave appropriate meds and stabilized the patient.Procedure continued as normal.
Additional Manufacturer Narrative
Information received from the hospital states "regarding intra-procedural bradycardic event during microwave ablation of hepatic lesion.There is no evidence to support that bradycardia is/was related to thermal ablation produced by microwave probe.Patient was discharged home without incident and a consult was placed for outpatient cardiology follow-up." device history record review did not show any issues with the antenna or the generator.Both met all specifications at the time of their release.

• Brand Name: MICROTHERMX MICROWAVE ABLATION SYSTEM
• Common Device Name: MICROWAVE ABLATION SYSTEM AND ACCESSORIES
• Manufacturer (Section D): ENDOCARE INC.; 9825 spectrum dr.; building 2; austin TX 78717
• MDR Report Key: 9191488
• Report Number: 3008262715-2019-00242
• Device Sequence Number: 13529412
• Product Code: NEY
• UDI-Device Identifier: 00810563020540
• UDI-Public: 810563020540
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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 Expiration Date: 09/01/2020
• Device Model Number: SWST-1420
• Device Lot Number: Y083
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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: 73 YR