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

Model Number A-TCSE-F

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  Injury  

Event Description

During an ablation procedure there was virtual instability of the ablation catheter so geometry had to be performed several times using a different approach.It was noted that the impedance on the catheter tip appeared higher than normal.Given the ongoing instability, isolation of the left veins was not performed due to the extended troubleshooting of repeating geometry creation.There were no adverse consequences to the patient.

Manufacturer Narrative

One uni-directional, curve f, tacticath sensor enabled contact force ablation catheter was received for evaluation.No visual anomalies were noted.Electrical testing of the returned device determined electrodes 1-4 and the magnetic sensor met specifications for acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported display and impedance issues remains unknown.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE F
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8414191
• MDR Text Key: 138585667
• Report Number: 3005334138-2019-00142
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027696
• UDI-Public: 05415067027696
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: A-TCSE-F
• Device Lot Number: 6535655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other