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

Model Number A-TCSE-D

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

Patient Problem Hematoma (1884)

Event Date 10/10/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

One day following an af ablation procedure, an intramural hematoma of the left atrial free-wall was observed.The patient collapsed at discharge and underwent emergency cardiac surgery with preliminary reports of an intramural hematoma of the left atrial free-wall.Following the surgery the patient was transferred to the icu.There were no performance issues with any abbott devices.

Manufacturer Narrative

Additional information: g4, g7, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED UNID CURVE D
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 10802687
• MDR Text Key: 215097215
• Report Number: 3008452825-2020-00573
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027689
• UDI-Public: 05415067027689
• 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: 11/22/2020

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
• Device Expiration Date: 05/31/2021
• Device Model Number: A-TCSE-D
• Device Catalogue Number: A-TCSE-D
• Device Lot Number: 7316429
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention