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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. TACTISYS QUARTZ ABLATION SYSTEM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
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.
 
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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, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key10752513
MDR Text Key213649017
Report Number2184149-2020-00185
Device Sequence Number1
Product Code OAE
UDI-Device Identifier07640157990194
UDI-Public07640157990194
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
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 NumberPN-004 400
Device Catalogue NumberPN-004400
Device Lot Number6976666
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/20/2020
Initial Date FDA Received10/28/2020
Supplement Dates Manufacturer Received01/18/2021
Supplement Dates FDA Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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