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

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

Patient Problems Nerve Damage (1979); Stenosis (2263)

Event Type  Injury  

Event Description

Related manufacturer report number: 3005334138-2023-00536.The following was published in revista portuguesa de cardiologia, portuguese journal of cardiology 41: 17-26.John wiley and sons inc (2022) "efficacy of extended antrum ablation based on substrate mapping plus pulmonary vein isolation in the treatment of atrial fibrillation"; chen, lin.The objective of this study was to assess the efficacy and safety of extended antrum ablation based on electrophysiological substrate mapping plus pvi in af patients who underwent cryoballoon ablation.In this observational study, a total of 121 paroxysmal af patients and 80 persistent af patients who did not achieve the procedure endpoint after cryoballoon ablation received extra extended antrum ablation (eaa) based on electrophysiological substrate mapping via radiofrequency ablation (eaa group).As a control group (pvi group), among paroxysmal af and persistent af patients, we conducted a propensity score-matched cohort, in whom only pvi was completed.The average follow-up time was 15.27±7.34 months.Compared with pvi group, paroxysmal af patients in the eaa group had a significantly higher rate of af-free survival and af, atrial flutter, or atrial tachycardia (aflat) -free rate survival.Persistent af patients in the eaa group also had a significantly higher rate of af-free survival and aflat-free survival than pvi group.Complication rates did not significantly differ between both groups, in either paroxysmal af or persistent af patients.A total of five in 201 patients in eaa group experienced complications including left superior pulmonary vein stenosis and phrenic nerve injury.

Manufacturer Narrative

Concomitant device: swartz¿ introducer, unknown.

Manufacturer Narrative

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 PATH¿ DUO ABLATION CATHETER
• 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: 18166159
• MDR Text Key: 328478479
• Report Number: 2030404-2023-00074
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060019
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening