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

Model Number	60SF2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Blood Loss (2597)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 10725383
• Report Number: 3008592544-2020-00055
• Device Sequence Number: 3312480
• Product Code: OCL
• UDI-Device Identifier: 00763000114619
• UDI-Public: 00763000114619
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR