MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60SF2

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

Patient Problem Complete Heart Block (2627)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient had the following concomitant surgical procedures mitral valve repair, tricuspid valve repair and coronary artery bypass grafting (four anastomoses) through sternotomy.During the same procedure ((b)(6) 2019) a cryoflex probe powered by a cryoconsole and a cardioblate bp2 clamp and a cardioblate maps powered by a cardioblate generator were used.The left atrial appendage was successfully closed.Left pulmonary vein (pv) and right pulmonary vein (pv) conduction block were achieved.On ((b)(6) 2019) the patient experienced right bundle branch block.The patient status is not recovered/not resolved.The adverse event was deemed by the site as possibly related to the concomitant procedure, study procedure and cryoflex probe.The adverse event was deemed by the site as unlikely related to the cardioblate bp2 clamp.

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9265651
• MDR Text Key: 164589742
• Report Number: 3008592544-2019-00055
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00643169183889
• UDI-Public: 00643169183889
• 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
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• Date Device Manufactured: 04/24/2018
• 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: 74 YR