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 Consequences Or Impact To Patient (2199)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned due to a contact force issue.Contact force was displayed when connected to the tactisys unit, with no error messages noted.The device met specifications for optical signal properties and the deformable body thermocouple met specifications during electrical testing; however, multiple short circuits were detected, consistent with the reported contact force issue.Fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle.In addition, dried saline was noted within the connector plug, consistent with the short circuits detected.No leaks were identified during leak testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detected saline in the catheter and fluid within the tygon tubing remains unknown.

Event Description

This report is to advise of an event observed during analysis, confirming a short circuit and leak within the catheter.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10441679
• MDR Text Key: 204019769
• Report Number: 3008452825-2020-00395
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130026
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 7351160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2020
• 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