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

Model Number	CA30L1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Blood Loss (2597)
Date of Event	07/11/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after six cycles of ablation was performed with each had six minutes duration at 100 watts, a bleeding with a big hematoma occurred from one of the needle tracks in the liver.They noted that an anonymized cd with ct scans was available.They successfully stopped the bleeding by catheter embolization and the patient was stabilized.The bleeding did not occur from ablation area, but from a vessel on one of the antenna trajectories.The patient was placed in the intensive care unit due to the hemorrhage that occurred during the liver ablation procedure.Two days after they performed necessary resuscitation on the patient, but were not successful and the patient died.The site indicated that the ablation system worked properly.A cause of death has not yet been determined, but sepsis, liver and kidney failure, and a lung embolism are possible.

• 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: 7781369
• Report Number: 3006451981-2018-00565
• Device Sequence Number: 1391685
• Product Code: NEY
• UDI-Device Identifier: 10884521189553
• UDI-Public: 10884521189553
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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 Expiration Date: 03/23/2019
• Device Model Number: CA30L1
• Device Catalogue Number: CA30L1
• Device Lot Number: S7JG032LX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/14/2018
• 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
• Patient Age: 41 YR