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 Problems Ulceration (2116); Blood Loss (2597)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure ((b)(6) 2018) a cardioblate lp clamp and cryoflex probe were used through a sternotomy to treat the patients af.Left pulmonary vein conduction block was not performed due to a possible clot in the left atrial appendage.Right pulmonary vein (pv) conduction block was not performed.The patient had a concomitant surgical procedure of amputated/excised and oversewn.On (b)(6) 2018 the patient experienced a gastrointestinal bleed.A colonoscopy was carried out and it showed multiple ulcers in ascending and descending colon.During the colonoscopy a hemostatic clip was placed at one bleeding site.The patient¿s haemoglobin was 7.5.The patient was hospitalized from (b)(6).The patient was given a blood transfusion and concomitant or additional medication because of this adverse event.The adverse event was deemed as unlikely related to the study procedure and unlikely related to the concomitant procedure.The customer stated that the stress of surgery may have contributed.The adverse event was deemed as not related to the study devices.

Manufacturer Narrative

The patient had a concomitant surgical procedure of aortic valve replacement and mitral valve replacement through sternotomy.The left atrial appendage was successfully amputated/excised and oversewn.If information is provided in the future, a supplemental report will be issued.

• 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: 8332024
• MDR Text Key: 135914078
• Report Number: 3008592544-2019-00006
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00763000114626
• UDI-Public: 00763000114626
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2020
• Device Model Number: 60SF3
• Device Catalogue Number: 60SF3
• Device Lot Number: 28418004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 08/23/2019
• Date Device Manufactured: 10/25/2018
• 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: 72 YR