MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A-TCSE-D

Device Problem Optical Problem (3001)

Patient Problem Transient Ischemic Attack (2109)

Event Date 07/28/2023

Event Type  Injury  

Event Description

Post procedure, the patient experienced vision changes in the left eye involving an enlarged blind spot consistent with a transient ischemic attack.A head and neck cta came back negative, an mri was negative for infarct.Neuro and ophthalmology were consulted, and an eye exam should not sign of retinal artery occlusion or optic neuropathy.After a few hours the visual symptoms resolved which led to conclusion it was a transient ischemic attack.The patient was already on eliquis and atorvastatin.The patient was stable and discharged with a scheduled follow-up.Additionally, during the procedure there was an issue with no contact force.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were received.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 transient ischemic attack could not be conclusively determined.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17628845
• MDR Text Key: 322020002
• Report Number: 3008452825-2023-00365
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027689
• UDI-Public: 05415067027689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-TCSE-D
• Device Lot Number: 9077893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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): Other
• Patient Age: 69 YR
• Patient Sex: Male