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

Model Number A-TCSE-DF

Device Problems Optical Problem (3001); No Apparent Adverse Event (3189)

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

Event Date 06/07/2023

Event Type  Death  

Event Description

During a pulmonary vein isolation cti procedure, it was noted that there was an error ¿no contact force signal or out of range.Check catheter optical connection.¿ which resulted in cancellation of the procedure and the patient later expired.This error occurred while mapping a leak in the cti line after successful pulmonary vein isolation.After troubleshooting and reconnecting the catheter, the issue did not resolve.Instead of pulling a new catheter the physician elected to end the procedure, as there was equivocal evidence for block along the line, and there were time constraints as there was to be a second case afterwards.After the procedure, the patient had low o2 sats in the 80s.Upon discussion with the physician, he stated that this was unrelated to the catheter issue that occurred during the case.High right atrial pressures and a right to left shunt was noted after the case as the likely cause of the low o2 saturation levels.The patient was kept overnight and is recovering.After the case, the patient could not tolerate being extubated.The patient was brought into the lab on (b)(6) 2023 to attempt a pfo/asd closure with hopes that this would fix the patient's low saturation levels.Before proceeding with placing the closure device the pulmonary veins were checked and confirmed to be isolated and the cti was confirmed to be blocked using an advisor hd grid mapping catheter.Ultimately the physicians elected not to proceed with the closure.The patient passed away on (b)(6) 2023.

Manufacturer Narrative

One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.Optical fibers 2-3 no longer met specifications for optical properties and no contact force was displayed when the returned device was connected to the tactisys quartz unit.Further investigation revealed a gouge in the shaft material between electrodes 1 and 2, consistent with fluid ingress and a loss of force data during the procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the gouge in the shaft material remains unknown.The cause of the patient death was not confirmed to be device related.

Event Description

During a pulmonary vein isolation cti procedure, it was noted that there was an error ¿no contact force signal or out of range.Check catheter optical connection.¿ this error occurred while mapping a leak in the cti line after successful pulmonary vein isolation.After troubleshooting and reconnecting the catheter, the issue did not resolve.Instead of pulling a new catheter the physician elected to end the procedure, as there was equivocal evidence for block along the line.After the procedure, the patient had low o2 saturations in the 80s.Upon discussion with the physician, he stated that this was unrelated to the catheter issue that occurred during the case.High right atrial pressures and a right to left shunt was noted after the case as the likely cause of the low o2 saturation levels.The patient was kept overnight and is recovering.After the case, the patient could not tolerate being extubated.The patient was brought into the lab on (b)(6), 2023, to attempt a pfo/asd closure for a pre-existing pfo with hopes that this would fix the patients low saturation levels.Before proceeding with placing the closure device the pulmonary veins were checked and confirmed to be isolated and the cti was confirmed to be blocked using an hd grid mapping catheter.Ultimately the physicians elected not to proceed with the closure.The patient passed away on (b)(6), 2023.Per the physician, the cause of death was not related to any abbott device or the procedure.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17238043
• MDR Text Key: 318200454
• Report Number: 3008452825-2023-00282
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 8911044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• 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
• Patient Outcome(s): Death