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 Problems Anemia (1706); Blood Loss (2597)

Event Date 08/27/2020

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 mitral valve replacement through sternotomy.During the same procedure a cryoflex probe powered by a cryoconsole, and cardioblate lp clamps powered by a ft-10 generator were used.The left atrial appendage was successfully amputated/excised and over-sewn.Left pulmonary vein (pv) and right pulmonary vein (pv) conduction block were successfully achieved.Three days post index procedure, the patient experienced hematological acute blood loss anemia.The patient's hemoglobin had drifted down to 6.9g/dl and it was treated with two units of red blood cells the patient recovered on the following day.The adverse event was deemed by the site as possibly related to the concomitant procedure but not related to the study devices or the study procedure.The site stated that this was a common occurrence following cardiac surgery.The clinical events committee (cec) deemed a relationship between the concomitant procedure and study procedure to the adverse event and a possible relationship to the study devices with the exception of the cryoconsole.The cec deemed that the adverse event was not related to the cryoconsole.

• 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: 10725383
• MDR Text Key: 212688005
• Report Number: 3008592544-2020-00055
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00763000114619
• UDI-Public: 00763000114619
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• Date Device Manufactured: 05/22/2019
• 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: 62 YR