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

Model Number	CA20L2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Abscess (1690); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
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 a procedure, since the lesion was relatively large, 3 successive ablations (each with 100w/10 minutes) with complete antenna removal and re-insertions after each ablation cycles were planned.When the antenna was removed after the 2nd ablation cycle, the doctor noticed that the ceramic tip of the antenna remained in the liver after ablation.The physician waited a couple of seconds after the ablation and rotated the antenna before slowly removing it (hot retraction).For the last ablation, a new antenna was opened.The intervention could be finished as planned with no noticeable complications other than the mentioned incidence.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had a tip detached.Functional testing found the ceramic tip was missing and was not returned.It was reported that the device had a component that disengaged.The reported issue was confirmed.The most likely cause was traced to a component failure.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: b5, fdp and ime codes, g4, h6 h6 patient codes - c64343 (septic).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
According to the reporter, during a percutaneous ablation procedure, since the lesion was relatively large (27 x 28mm), 3 successive ablations (each with 100w/10 minutes) with complete antenna removal and re-insertions after each ablation cycles were planned.The case was done with a cas-one stereotactic navigation system from cascination.There was adherence to recent ifu (instructions for use) updates during this case, pause 5 seconds before moving antenna after ablation cycle ends and no lateral force to antenna through needle guide or when antenna was advanced into patient.When the antenna was removed after the 2nd ablation cycle, the doctor noticed that the ceramic tip of the antenna remained in the liver after ablation.An imaging was done to identify location of the tip that was deep in the 8th segment.The physician waited a couple of seconds after the ablation and rotated the antenna before slowly removing it (hot retraction).For the last ablation, a new antenna was opened.The intervention could be finished as planned with no noticeable complications other than the mentioned incidence.The patient was aware that the tip was left behind and removal was anticipated in the meantime the patient developed an abscess at the ablation site and was septic.It was noted that a surgical removal was too risky at the moment and they would place a percutaneous drainage catheter and re-assess the situation in a couple of days.The physician prescribed antibiotics.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 10381825
• Report Number: 3006451981-2020-00115
• Device Sequence Number: 13881128
• Product Code: NEY
• UDI-Device Identifier: 10884521706590
• UDI-Public: 10884521706590
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K163105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/05/2021

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: 03/04/2022
• Device Model Number: CA20L2
• Device Catalogue Number: CA20L2
• Device Lot Number: S0CG005X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/21/2020; 11/06/2020; 01/14/2021
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/09/2020; 11/12/2020; 02/05/2021
• 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: 69 YR
• Patient Weight: 56