MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER; IRRIGATED ABLATION CATHETER

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

Patient Problem Perforation of Esophagus (2399)

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: flexibility catheter, event date unknown.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.

Event Description

Related manufacturer reference number: 3005334138-2020-00101.The following was published in the international journal of cardiology in an article titled ¿elongation of the high right atrium to coronary sinus conduction time predicts the recurrence of atrial fibrillation after radiofrequency catheter ablation¿ by kanemaru y, arima y, kaikita k, et al., 18 november 2019.¿the impact of intra-atrial conduction delay on the recurrence of atrial tachyarrhythmia after radio frequency catheter ablation (rfca) has not been fully elucidated.In this study, 155 af patients who were in sinus rhythm at the start of rfca were analyzed at the kumamoto university hospital from january 2011 to march 2017.The conduction time from the onset of the earliest atrial electrogram at the high right atrium (hra) to the end of the latest electrogram at the coronary sinus (cs) during sinus rhythm was defined as hra-cs conduction time.Pulmonary vein isolation (pvi) was performed followed by linear roof lesion and complex fractionated atrial electrogram (cfae) ablation until af termination.Of the 155 patients, four experienced esophageal injuries.The conclusion was that the hra-cs conduction time was the primary influencing factor that predicted the recurrence of atrial tachyarrhythmia after catheter ablation.(https://doi.Org/10.1016/j.Ijcard.2019.10.044).

• Brand Name: THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER
• Type of Device: IRRIGATED ABLATION CATHETER
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9812310
• MDR Text Key: 187933088
• Report Number: 2030404-2020-00018
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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