MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. TACTISYS QUARTZ ABLATION SYSTEM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number PN-004 400

Device Problem Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

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 delay occurred due to troubleshooting steps with prolonged anesthesia.Upon connection, the force data from the tacticath catheter was correctly displayed and a reset was done.Following mapping, during ablation contact force information was no longer available; only purple double dots.All connections were verified.The catheter was replaced with no resolution.A third catheter was tried with no success.Therefore, it was decided to check the fiber optic connection of the tactisys, and air was used to ¿clean¿ the port.Following which, the third catheter was connected, and contact force data successfully displayed.The procedure was completed with no adverse patient consequences.

Manufacturer Narrative

One tactisys¿ quartz was received for evaluation.Visual inspection of the returned device verified the connectors, switches, and labels had no physical damage.The returned quartz was powered on and an audible beep was observed to indicate a successful boot and communication was established.The field reported event was confirmed as contact force was not observed after connecting a known-good catheter.Fiso diagnostic identified a degraded signal at fiso compact module on slot 1.Internal inspection confirmed the fiso compact module on slot 1 was non-functional and the fiso compact module was temporarily replaced with a known-good unit.Functionality was restored as valid contact force was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause was isolated to the fiso compact module on slot 1.Based on the information provided and investigation performed, the root cause was isolated to the fiso compact module on slot 1.

• Brand Name: TACTISYS QUARTZ ABLATION SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10752513
• MDR Text Key: 213649017
• Report Number: 2184149-2020-00185
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: 07640157990194
• 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: 01/18/2021

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 Model Number: PN-004 400
• Device Catalogue Number: PN-004400
• Device Lot Number: 6976666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other