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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CRYO CONSOLE 65CS1-002R CONSOLE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
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MEDTRONIC, INC. CRYO CONSOLE 65CS1-002R CONSOLE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE Back to Search Results
Model Number 65CS1-002R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Extubate (2402); Respiratory Failure (2484)
Event Date 10/30/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event 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 re-intubation 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.
 
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.
 
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 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.
 
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Brand Name
CRYO CONSOLE 65CS1-002R CONSOLE
Type of Device
SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
Manufacturer (Section D)
MEDTRONIC, INC.
3800 annapolis lane
minneapolis MN 55447
MDR Report Key9769086
MDR Text Key181478489
Report Number3008592544-2020-00011
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
PMA/PMN Number
K121878
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Type of Report Initial,Followup,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number65CS1-002R
Device Catalogue Number65CS1-002R
Was Device Available for Evaluation? No
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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