MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	CA20L1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after withaferin a (wfa) for liver cancer, the lesion of the tumor previously ablated with proton beam reoccurred.The device was used on the 4th day, and the protocol was 45w for one minute, 60w for one minute, 75w for three minutes, and route ablation was performed at 60w.After that, it was confirmed that the ablation was well performed and the patient condition (the readings for the liver) was also good.However, 3 days later, the patient complained of poor physical condition.Upon check, bleeding was found from the puncture route (artery), and embolization was performed.There was no problem with the patient current condition.The doctor said that he had never met bleeding event 3 days after a procedure.The amount of bleeding was unknown.

• Brand Name: EMPRINT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8035324
• Report Number: 1717344-2018-01435
• Device Sequence Number: 1303116
• Product Code: NEY
• UDI-Device Identifier: 10884521189546
• UDI-Public: 10884521189546
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

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: CA20L1
• Device Catalogue Number: CA20L1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 11/02/2018
• 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: Other