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 Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During the procedure, a clinically significant delay was noted.The ablation catheter was advanced into the left atrium (la) and ablation was performed without issue.The catheter was withdrawn from the la and a sl0 sheath was advanced into the right atrium (ra).The ablation catheter was then removed and reinserted through the sl0 sheath into la and no contact force values were observed.The catheter was unplugged, plugged back in and the reset button on the tactisys was pressed and a long ¿boop¿ sound was heard.Another catheter was used to complete the procedure with no consequences to the patient.The physician stated that troubleshooting caused a significant delay (approximately 12 minutes).

Manufacturer Narrative

Additional information: d10, g4, h2, h3, h6.One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.Optical fiber 3 no longer met specifications for optical signal properties and no contact force was displayed when the returned device was connected to a tactisys unit.Further investigation revealed optical fiber 3 was fractured at the distal end of the handle under the strain relief, consistent with the optical signal issue observed and the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the optical fiber fracture is consistent with damage during use.

• 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: 10733135
• MDR Text Key: 212978506
• Report Number: 3005334138-2020-00511
• 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: 11/02/2020

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: 09/30/2021
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 7477889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1