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 Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer ref: 2184149-2020-00133, 3005334138-2020-00393.During the procedure, a clinically significant delay was noted.During the procedure, the tacticath was not recognized and a second tacticath was used which resolved the issue.However, the lsi/sti values did not update as expected.The tactisys was power cycled but the issue remained.The optical port on the tactisys was cleaned, which did not resolve the issue.A third tacticath was used to continue the procedure.During the last hour of the procedure, the generator started to not deliver power despite the data be displayed as expected.When ablation was attempted to be delivered, the impedance reading dropped to approximately 94 ohms.The issue occurred several times and when the systems were power cycled, the issue remained.It was also noted that the ampere foot pedal did not function as well.The foot pedal was unplugged and reseated on the ampere system, and then the ablation functionality returned.The procedure was then completed with no adverse consequences to the patient.However, a clinically significant delay in procedure was noted.

Manufacturer Narrative

Additional information: d10, g4, h2, h3, h6, h8.Optical fibers 1-3 met specifications for optical properties.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.The cause of the reported communication issue 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; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10487364
• MDR Text Key: 205466980
• Report Number: 3005334138-2020-00392
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 7447711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPERE RF ABLATION GENERATOR; TACTICATH CONTACT FORCE CATHETER; AMPERE RF ABLATION GENERATOR; TACTICATH CONTACT FORCE CATHETER
• Patient Outcome(s): Other