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 Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 04/07/2021

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 left atrial myxoma excision, insertion va ecmo through minimally invasive / thoracotomy.During the same procedure on ((b)(6) 2021) a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a cardioblate generator were used.The left atrial appendage was closed.Left pulmonary vein (lpv) was not performed as the procedure was a right mini-thoracotomy approach and right pulmonary vein (rpv) conduction block was achieved.On ((b)(6) 2021) the patient experienced a pulmonary hemorrhage.On coming off bypass, the customer noted frank bleeding from ett along with hypotension.They were unable to ventilate off bypass.Pulseless electrical activity (pea) arrest occurred during a period of hypotension and hypoxemia.The patient was placed on ecmo.18 units packed red blood cells (prbcs) were given in the operating room.The patient returned to the operating room on (b)(6) 2021 for further clot evacuation.An additional 8 units of packed red blood cells (prbcs) were given.The hematocritwas normal by discharge.The patients condition was classed as recovered/resolved (b)(6) 2021.The adverse event was deemed by the site as not related to the study devices or procedure and possibly related to the concomitant procedure.The site provided the following rationale for the relationship to the concomitant procedure; bleeding related to dissection of adhesions around lower lobe of lung.Dissection needed for performance of procedure.The adverse event was deemed by the sponsor as related to the study devices, study procedure and concomitant procedure.The clinical events committee (cec) deemed that the adverse event was possibly related to the study devices and casually related to the concomitant and study procedure.

Manufacturer Narrative

Medtronic received additional information that the adverse event was deemed by the site as not related to the study devices or procedure and causally related to the concomitant procedure.The site provided the following rationale for the relationship to the concomitant procedure; bleeding related to dissection of adhesions around lower lobe of lung.Dissection needed for performance of procedure.The adverse event was deemed by the sponsor as related to the study procedure and concomitant procedure but not related to the study devices.The clinical events committee (cec) deemed that the adverse event was casually related to the concomitant and study procedure.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: 12195008
• MDR Text Key: 262410525
• Report Number: 3008592544-2021-00028
• 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: K191526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2021
• Device Model Number: 60SF3
• Device Catalogue Number: 60SF3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2023
• Date Device Manufactured: 11/26/2019
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American