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

Model Number A-TCSE-DD

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

One bi-directional, curve d-d, tacticath sensor enabled contact force ablation catheter was received for evaluation.Visual inspection revealed electrode 2 was displaced from its original location and was separated from conductor wire 2.The catheter was connected to an ensite precision system and electrode 2 appeared distorted and read as an open circuit during electrical testing.Electrode ring 2 was distally displaced on the shaft and was separated from conductor wire 2, consistent with the open circuit and display issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the displaced electrode ring is consistent with damage during use.

Event Description

This report is to advise of an event observed during analysis confirming a dislodged electrode of the catheter.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-D
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8700223
• MDR Text Key: 148031400
• Report Number: 3005334138-2019-00309
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027634
• UDI-Public: 05415067027634
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: A-TCSE-DD
• Device Lot Number: 6687324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1