MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number	60SF3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	11/23/2018
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
During the procedure ((b)(6) 2018), a cyroflex probe and cardioblate bipolar clamp were used through sternotomy to treat the patients af.Left pulmonary vein (pv) and right pulmonary vein (pv) conduction block achieved.The patient had a concomitant surgical procedure of mitral valve replacement and amputated/excised and oversewn.Approximately 7 days post procedure the patient experienced complete heart block requiring a permanent pacemaker.The patient received a pacemaker.Patient was discharged 13 days post procedure ((b)(6) 2018) with sinus rhythm.The adverse event was deemed as been not related to the device but possibly related to the study and concomitant procedure.Need for a pacemarker implantation is a known complication to surgical ablation and mitral valve replacement.The patient had a concomitant surgical procedure of mitral valve replacement and amputated/excised and oversewn.
Additional Manufacturer Narrative
Additional information: a.Patient information 4.Weight in kgs.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Common Device Name: 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8173453
• Report Number: 3008592544-2018-00069
• Device Sequence Number: 2792613
• Product Code: OCL
• UDI-Device Identifier: 00643169183865
• UDI-Public: 00643169183865
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 02/19/2020
• Device Model Number: 60SF3
• Device Catalogue Number: 60SF3
• Device Lot Number: 05018008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 11/22/2024
• Date Device Manufactured: 03/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White