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

Model Number 60SF3

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

Patient Problem Pericardial Effusion (3271)

Event Date 07/03/2022

Event Type  Injury  

Event Description

The patient had a concomitant surgical procedure of tricuspid valve repair through a minimally invasive thoracotomy.During the same procedure on ((b)(6) 2022) a cryoflex probe and cardioblate ft-lp clamp were used with an ft-10 generator.The left atrial appendage was closed.Left pulmonary vein (lpv) was and right pulmonary vein (rpv) conduction block were not performed as the patient had multiple failed cardioversions.On ((b)(6) 2022) the patient experienced pericardial effusion.The patient presented to the emergency department with increased shortness of breath for two days with right upper chest tightness and intermittent right arm pain.The patient¿s breathing was worse when lying flat.Concomitant/additional medication was given and pericardiocentesis was performed.The patient status was recovered/resolved on (b)(6) 2022.The adverse event was deemed by the site as causal relationship to the concomitant procedure and not related study procedure or study devices.The adverse event was deemed by the sponsor as related to the concomitant procedure and study procedure and possibly related to the study devices.Medtronic received additional information that the site reported left atrial appendage (laa) closure as concomitant procedure for subject (b)(6).Site is queried to update the crf with other procedure if applicable.

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 investigation - review of the complaint with the office of medical affairs determined this would be related to the concomitant procedure and not related to the study devices.There were no patient adverse effects, will continue to monitor for future events 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: CRYOFLEX SURGICAL ABLATION PROBE
• 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: 15164681
• MDR Text Key: 297245247
• Report Number: 3008592544-2022-00039
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00763000114626
• UDI-Public: 00763000114626
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 60SF3
• Device Catalogue Number: 60SF3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 140 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White