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

Model Number A-TCSE-DF

Device Problem Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

This report is to advise of a short circuit found during analysis.

Manufacturer Narrative

One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.A short circuit between the tip thermocouple (tct) and deformable body thermocouple (tc2) was detected during electrical testing.The short circuit was isolated to the green tct wire and both tc2 wires within the tubing between the barb splitter and the 19-pin connector.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported short circuit between remains unknown.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
• 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
• 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: 15381496
• MDR Text Key: 305515532
• Report Number: 3008452825-2022-00584
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• 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
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 8463356
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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 Age: 18 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White