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

Model Number 60SF3

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

Patient Problem Complete Heart Block (2627)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event 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.

• 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: 8173453
• MDR Text Key: 130629517
• Report Number: 3008592544-2018-00069
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00643169183865
• UDI-Public: 00643169183865
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/04/2018
• Date Device Manufactured: 03/19/2018
• 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): Required Intervention
• Patient Age: 78 YR