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 Problems Optical Problem (3001); Output Problem (3005)

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

Event Date 02/24/2021

Event Type  malfunction  

Event Description

Related mfr number: 3008452825-2021-00123.During a pulmonary vein isolation ablation procedure, there was a delay of one and a half hours to the procedure.Access was gained to the left atrium, and an ablation catheter was prepped without issue.Once the catheter was advanced to the left atrium, noise was seen.There were no issues with contact force data.The ampere cable to the tactisys was replaced, and the tactisys was reset, but the issue remained.The noise was only seen while the tactisys was powered on.The ensite system was restarted multiple times to resolve the issue, and a new case was started, but the noise persisted.A replacement catheter was opened and primed, and there was no noise observed when it was used.However, it could not be zeroed due to an error stating that the catheter was for single use only.Restarting the tactisys, the generator, and the ensite system did not resolve the issue.Going back to the original study also gave the same catheter for single use only message.A spare tactisys was connected to the catheter, but the same error occurred again.The first catheter was used with the replacement tactisys, and noise was observed again.A third tacticath was connected to the spar tactisys, and it connected and zeroed without issue.No noise was observed on the third catheter.The case continued with no adverse consequences to the patient.Troubleshooting took 1.5 hours total.The third tacticath, which was used to complete the procedure, was tested with the original tactisys and experienced no issues.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6.One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.The device was returned due to an error message that the catheter can only be used once.The catheter eeprom had been programmed using a tactisys unit that did not have the date stamp feature disabled resulting in the reported event.Actions have been taken to prevent reoccurrence.

• 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
• MDR Report Key: 11498518
• MDR Text Key: 241305605
• Report Number: 3008452825-2021-00112
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 7596642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 80