MAUDE Adverse Event Report: MEDTRONIC, INC.; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number CRYO-UNKNOWN

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Ventricular Fibrillation (2130); Heart Block (4444)

Event Date 05/26/2023

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

It was reported that during a cryo ablation procedure, after transeptal puncture another manufacturer¿s sheath was replaced with a sheath.The balloon catheter was inserted into the sheath but it was not connected to the flush and needed to be aspirated.The balloon catheter was then removed from the patient and prepped again.The sheath was then aspirated, and the balloon catheter was reinserted into the patient.The first freeze was carried out without isolation.During the second freeze the patient became hypotensive, and their heart rate dropped.The patient was in complete heart block with st elevation.The patient then went into ventricular tachycardia (vt) and then ventricular fibrillation (vf).Chest compressions were carried out and medications were given and the patient had a return of spontaneous circulation (rosc).A cardiac catherization and testing was carried out and no abnormalities were noted.The patient¿s blood pressure became stable, st segmentation resolved, and sinus rhythm returned to normal.Imaging was performed and no signs of effusion were noted.The case was completed with cryo.Hospitalization was extended.The operating physician believed an air embolus was introduced into the body due to improper preparation or insertion of the balloon catheter or due to lack of aspirating and flushing the sheath properly.The issue completely resolved once the air embolus resolved.No further patient complications have been reported as a result of this event.

• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17166932
• MDR Text Key: 317534918
• Report Number: 2182208-2023-01703
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2023

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: CRYO-UNKNOWN
• Device Catalogue Number: CRYO-UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFAPRO28 BALLOON CATHETER, 4FC12 SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male