MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOCONSOLE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number R65CS1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Flutter (1730)

Event Date 11/28/2022

Event Type  Injury  

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 through sternotomy.During the same procedure a cryoflex probe powered by a cryo console, and a cardioblate lp clamp powered by an ft-10 generator were used.The left atrial appendage was stapled.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block was achieved.21 days later the patient experienced atrial flutter.Event was treated with medication and external cardioversion.3 days later, the patient recovered.The adverse event was deemed by the site as related to concomitant procedure, study procedure and the cryo console but not related to the cryoflex probe, cardioblate lp clamp or the ft-10 generator.

Manufacturer Narrative

Medtronic received additional information that the adverse event was deemed by the site as possible related to concomitant procedure, study procedure and the cryoflex probe, cardioblate lp clamp.Correction: the adverse event was deemed by the sponsor as related to concomitant procedure, study procedure and the cryo console but not related to the cryoflex probe, cardioblate lp clamp or the ft-10 generator.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

Correction section a patient information a2 (age at event) and a5a (ethnicity): these fields have been updated.Correction section a patient race a5b (patient race): this field has been updated.Correction b5: the patient had a concomitant surgical procedure of aortic valve replacement, ascending aorta replacement, maze, left atrial appendage (laa) ligation through sternotomy.During the same procedure on (b)(6) 2022 a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by an ft-10 generator were used.The left atrial appendage was stapled.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were achieved.21 days later, on (b)(6) 2022 the patient experienced atrial flutter.The patient came in during their 1 month visit and was found to be in atrial flutter.The adverse event was treated with medication, percutaneous intervention and external cardioversion.Three days later, the patient recovered.The adverse event was deemed by the sponsor as related to the concomitant procedure, study procedure and the cryoconsole but not rel ated to the cryoflex probe, cardioblate lp clamp or the ft-10 generator.The adverse event was deemed by the site as possibly related to the concomitant procedure, study procedure and the cryoflex probe, c ardioblate lp clamp but not related to the cryoconsole or the ft-10 generator.Correction h5 (label for single use): this field has been updated to no.Correction h6 (eval code conclusion): this field has been updated.Correction h8 (usage of device): this field has been updated to reuse.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: CRYOCONSOLE
• Type of Device: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15930718
• MDR Text Key: 304956676
• Report Number: 3008592544-2022-00077
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2023

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
• Device Operator: Health Professional
• Device Model Number: R65CS1
• Device Catalogue Number: R65CS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 12/01/2022; 01/06/2023
• Supplement Dates FDA Received: 12/22/2022; 01/09/2023
• Date Device Manufactured: 07/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White