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 Insufficient Information (3190)

Patient Problem Arrhythmia (1721)

Event Date 12/28/2021

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 aortic valve replacement, coronary artery bypass grafting (number of anastomoses: 2), and patent foramen ovale closure through sternotomy.During the same procedure ( (b)(6) 2021) a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a valleylab ft-10 generator were used.The left atrial appendage was successfully closed.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were successfully achieved.Approximately one month post index procedure ( (b)(6) 2021), the patient experienced a right bundle branch block, noticed on the one month ekg.No treatment was required.The adverse event was deemed by the site as possibly related to the cryoflex probe, cardioblate lp clamp, the study procedure and the concomitant procedure.It was stated that the maze procedure and heart surgery may result in a delay of the electrical conduction system of the heart.

• 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: 14102325
• MDR Text Key: 289178869
• Report Number: 3008592544-2022-00011
• 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: Physician
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: 60SF3
• Device Catalogue Number: 60SF3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Date Device Manufactured: 10/29/2020
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White