MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Stroke/CVA (1770); Nerve Damage (1979); Cardiac Perforation (2513); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Related manufacturing reference: 2030404-2024-00021, 2030404-2024-00022, 2030404-2024-00024.The following was published in aging and disease 15.1: 408-420.International society on aging and disease.(jan 1, 2024)."index and repeat ablation for atrial fibrillation in older versus younger patients: a propensity-score matching analysis"; ana isabel molina-ramos.The electrophysiological study and catheter ablation procedure for af were performed under deep sedation without the need for general anesthesia using a combination of midazolam, fentanyl and propofol.The catheter ablation procedure included two main techniques, rf and cb.The rf ablation was conducted with carto (biosense webster, irvine, ca, usa) and navx (endocardial solutions, saint paul, mn, usa) guidance systems, with the corresponding open-irrigated ablation catheters and updates throughout the duration of the study: thermocool and thermocool smarttouch (biosense, webster, irvine, ca, usa); therapy cool path and therapy cool flex (abbot, chicago, il, usa).The cb technique was exclusively a single-shot ablation of the pv ostium with 240-ms applications at -40 degrees celsius using arctic front and arctic front advance catheters (medtronic, minneapolis, mn, usa).Phrenic stimulation was performed to monitor nerve injury.A ct scan was previously performed to assess the anatomy of the pvs.For more details see molina-ramos et al.[13].The total duration of the follow-up was 30 months from the index ablation procedure.Patients were followed up in the outpatient clinic at 3, 6, 12, 18, 24 and 30 months by a cardiologist.At each follow-up time point, patients had an electrocardiogram and a holter monitor for 24 h or seven days depending on the frequency of symptoms.Minor complications were reported including 1 stroke, 2 tias, 3 pericardial effusions, and 7 incidents of phrenic nerve injury.

Event Description

Additional information received from the field confirmed that no abbott device was involved in the reported adverse events, making this event not reportable.

Manufacturer Narrative

Corrected data: b5 additional information: d9, g3, h2, h3, h6 the results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18888460
• MDR Text Key: 337473937
• Report Number: 2030404-2024-00023
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN; THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER; THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER
• Patient Outcome(s): Life Threatening