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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL TACTISYS QUARTZ ABLATION SYSTEM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number PN-004 400
Device Problem Communication or Transmission Problem (2896)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2020
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 report number: 2184149-2020-00181, 3008452825-2020-00588.During the procedure, the communication between ensite and ampere and tactisys was unstable, and when the catheter was connected, communication with ampere and tactisys was disconnected.When the tactisys was rebooted, communication was sometimes possible and sometimes not, and when the tacticath was connected, communication was stopped again.Since the same phenomenon occurred multiple times, the tactisys was repeatedly rebooted and eventually was able to communicate.However, because the study was stopped for more than 30 minutes, propofol was additionally administered to the patient.The contact force value was about 10 g before the rf delivery, but it increased rapidly to about 30 g immediately after the rf delivery.The procedure was completed without replacing the devices and there were no adverse consequences to the patient.
 
Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be determined.
 
Manufacturer Narrative
One tactisys¿ quartz was received for evaluation.The returned quartz was powered on and an audible beep was observed to indicate a successful boot.Communication was established.A known-good catheter was connected and valid contact force was observed.The field reported event was not reproducible as the quartz was left-on for an extended period and communication was maintained.He review determined the process was performed and completed in accordance with abbott specifications and procedures.The root cause remains undetermined as the field reported event was not reproducible.
 
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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 Key10767910
MDR Text Key214100303
Report Number2184149-2020-00180
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
PMA/PMN Number
P130026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/03/2021
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 NumberPN-004 400
Device Lot Number5823645
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/08/2020
Initial Date FDA Received11/01/2020
Supplement Dates Manufacturer Received12/20/2020
02/02/2021
Supplement Dates FDA Received12/20/2020
02/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMPERE GENERATOR; TACTICATH SE; AMPERE GENERATOR; TACTICATH SE
Patient Outcome(s) Other;
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