MAUDE Adverse Event Report: ST. JUDE MEDICAL 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 11/03/2020

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: 3008452825-2020-00620, 3008452825-2020-00621.During an atrial fibrillation ablation procedure, it was not possible to synchronize the contact force data with ensite precision and the procedure was cancelled.When the catheter was connected to the tactisys, the contact force did not synchronize.The tactisys was noted to be communicating with ensite precision and the catheter was also recognized by the system, but the contact force was still unavailable.When the contact force was attempted to be reset, both through the tactisys and ensite precision software button, the tactisys did not execute the function.It was then noted that the light on the tactisys intermittently turned green and red.The tactisys was rebooted several times, and the catheter was replaced, however the issue remained.The catheters were not inserted into the patient.The procedure was cancelled and there were no adverse consequences to the patient.

Manufacturer Narrative

One tactisys¿ quartz was received for evaluation at tech center.Visual inspection of the returned device verified the connectors, switches, and labels had no physical damage.The returned quartz was powered on and audible beep was observed to indicate a successful boot.Communication was established and a known-good catheter was connected.The field reported event was confirmed as no contact force was observed.Fiso diagnostic displayed that fiso module on slot 3 was degraded.Internal inspection verified all fiso modules were functional with the appropriate signal channel percentage.It was discovered the orange internal wiring for fiso module on slot 3 was non-functional.The wire was temporarily replaced with a known-good unit and functionality was restored as valid contact force was observed.The root cause was isolated to the orange wiring for fiso module on slot 3.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause was isolated to the internal battery on the system on module board.

Manufacturer Narrative

One tactisys¿ quartz (pn pn-004 400 sn 33621) was received for evaluation at tech center.Visual inspection of the returned device verified the connectors, switches, and labels had no physical damage.The returned quartz was powered on and audible beep was observed to indicate a successful boot.Communication was established and a known-good catheter was connected.The field reported event was confirmed as no contact force was observed.Fiso diagnostic displayed that fiso module on slot 3 was degraded.Internal inspection verified all fiso modules were functional with the appropriate signal channel percentage.It was discovered the orange internal wiring for fiso module on slot 3 was non-functional.The wire was temporarily replaced with a known-good unit and functionality was restored as valid contact force was observed.The root cause was isolated to the orange wiring for fiso module on slot 3.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The field reported event was confirmed.Based on the information provided to abbott and the investigation performed, the root cause was isolated to the orange wiring for fiso module on slot 3.

• Brand Name: TACTISYS QUARTZ ABLATION SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10859888
• MDR Text Key: 216836488
• Report Number: 2184149-2020-00192
• 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,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 6976665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TACTICATH ABLATION CATHETER, SENSOR ENABLED; TACTICATH ABLATION CATHETER, SENSOR ENABLED; TACTICATH ABLATION CATHETER, SENSOR ENABLED; TACTICATH ABLATION CATHETER, SENSOR ENABLED
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 72