MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH SENSOR ENABLED CONTACT FORCE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number A-TCSE-JJ

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

Patient Problem Perforation of Esophagus (2399)

Event Date 09/09/2021

Event Type  Injury  

Event Description

The patient presented with discomfort when swallowing two and a half weeks post atrial fibrillation ablation procedure ( (b)(6) 2021).A ct revealed an esophageal/pericardial sac fistula.The patient was taken off food and water for a few weeks and is recovering.There were no performance issues with any abbott devices used.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were received.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 fistula remains unknown.

• Brand Name: TACTICATH SENSOR ENABLED CONTACT FORCE ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12516032
• MDR Text Key: 272853371
• Report Number: 3005334138-2021-00582
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-TCSE-JJ
• Device Catalogue Number: A-TCSE-JJ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR