MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	CA15L2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914)
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an ablation procedure, the lesion was about 10-12cm deep in the liver where the surgeon had to avoid lung, heart, and diaphragm.The physician placed needle and readjusted a few times; with the movement in and out of the computed tomography (ct) scanner.The ct scanned immediately after re-positioning showed a lot of blood, but the patient was stable.The patient was treated for 10 minutes at 100w, treated additional 5 minutes with minimal repositioning.The procedure lasted for over 2 hours; generator functioned normally.Post-treatment ct image showed blood in the abdomen; described as ¿moderate¿ amount of bleeding and repeat ct obtained shortly after showing reduction in the amount of blood in cavity.Post-procedure the patient became hypotensive and hemodynamically unstable.It is "unclear of" the resuscitation efforts, but the patient was given multiple blood transfusions.The patient never regained stability and expired 6 hours post ablation.

• Brand Name: EMPRINT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 8117574
• Report Number: 3006451981-2018-00642
• Device Sequence Number: 16557442
• Product Code: NEY
• UDI-Device Identifier: 10884521703278
• UDI-Public: 10884521703278
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K163105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CA15L2
• Device Catalogue Number: CA15L2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/29/2018
• 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: Death