MAUDE Adverse Event Report: PERFUSION SYSTEMS CARDIOBLATE LP ABLATION BIPOLAR DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	60841
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extubate (2402); Respiratory Failure (2484)
Date of Event	10/30/2019
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
The patient had a concomitant surgical procedure of aortic valve replacement, mitral valve replacement through sternotomy.During the same procedure (b)(6) 2019) a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a cardioblate generator were used.The left atrial appendage was successfully amputated/excised and sutured closed.Left pulmonary vein (pv) and right pulmonary vein (pv) conduction block was not achieved due to patient being in atrial fibrillation.On the day after the procedure (b)(6) 2019) the patient needed reintubation which was treated with concomitant/additional medication and prolonged hospitalization.The patient recovered (b)(6) 2019).The adverse event was deemed by the site as causally related to the concomitant procedure and unlikely related to the study devices and the study procedure.This is much more likely to be related to the double valve procedure.
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.
Event or Problem Description
The patient had a concomitant surgical procedure of aortic valve replacement and mitral valve replacement through sternotomy.During the same procedure ((b)(6) 2019) a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a cardioblate generator were used.The left atrial appendage was successfully amputated/excised and sutured closed.Left pulmonary vein (pv) and right pulmonary vein (pv) conduction block was not achieved due to patient being in atrial fibrillation.On the day after the procedure ((b)(6) 2019) the patient experienced acute respiratory failure which necessitated re-intubation and treatment with concomitant/additional medication and prolonged hospitalization.The patient recovered ((b)(6) 2019).The adverse event was deemed by the site as causally related to the concomitant procedure and unlikely related to the study devices and the study procedure.This is much more likely to be related to the double valve procedure.

• Brand Name: CARDIOBLATE LP ABLATION BIPOLAR DEVICE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 9769183
• Report Number: 2184009-2020-00012
• Device Sequence Number: 2574611
• Product Code: GEI
• UDI-Device Identifier: 00885074359618
• UDI-Public: 00885074359618
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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 Expiration Date: 01/23/2022
• Device Model Number: 60841
• Device Catalogue Number: 60841
• Device Lot Number: X483
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR