MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT HP; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	CAGENHP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pseudoaneurysm (2605); Unintended Radiation Exposure (4565)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that after ablation, a pseudoaneurysm occurred.A 10mm tumor located about 8mm from a blood vessel was treated with 150w for 30 seconds.After treatment, doppler confirmed blood flow in the ablation area.Although the liver is a parenchymal organ, it was believed that it formed a pseudoaneurysm as blood infiltrated the ablation area.There was no intraprocedural imaging performed during the ablation.An additional ablation was performed to prevent blood leakage from the puncture route.For the pseudoaneurysm, there was slight leakage into the abdominal cavity, but it did not rupture significantly.Hemostasis was achieved by angiography performed by an interventional radiology (ivr) physician and the patient¿s condition subsequently stabilized.
Additional Manufacturer Narrative
Additional information: b5, g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that after ablation, a pseudoaneurysm occurred.A 10mm tumor located about 8mm from a blood vessel was treated with 150w for 30 seconds.After treatment, doppler confirmed blood flow in the ablation area.Although the liver is a parenchymal organ, it was believed that it formed a pseudoaneurysm as blood infiltrated the ablation area.There was no intraprocedural imaging performed during the ablation.An additional ablation was performed to prevent blood leakage from the puncture route.For the pseudoaneurysm, there was slight leakage into the abdominal cavity, but it did not rupture significantly.Hemostasis was achieved by angiography performed by an interventional radiology (ivr) physician and the patient¿s condition subsequently stabilized.After being discharged from the hospital, the patient has been to the outpatient clinic once, and the progress has been fine even then.
Additional Manufacturer Narrative
Additional information: g3 correction: rfr code was updated medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EMPRINT HP
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23767960
• Report Number: 3004962788-2025-00131
• Device Sequence Number: 16105916
• Product Code: NEY
• UDI-Device Identifier: 10884521781276
• UDI-Public: (01)10884521781276(11)240212
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2026

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 Model Number: CAGENHP
• Device Catalogue Number: CAGENHP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 12/24/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/12/2025; 01/08/2026
• Date Device Manufactured: 02/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown