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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number A-TCSE-DF
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2020
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: 2184149-2020-00133, 3005334138-2020-00393.During the procedure, a clinically significant delay was noted.During the procedure, the tacticath was not recognized and a second tacticath was used which resolved the issue.However, the lsi/sti values did not update as expected.The tactisys was power cycled but the issue remained.The optical port on the tactisys was cleaned, which did not resolve the issue.A third tacticath was used to continue the procedure.During the last hour of the procedure, the generator started to not deliver power despite the data be displayed as expected.When ablation was attempted to be delivered, the impedance reading dropped to approximately 94 ohms.The issue occurred several times and when the systems were power cycled, the issue remained.It was also noted that the ampere foot pedal did not function as well.The foot pedal was unplugged and reseated on the ampere system, and then the ablation functionality returned.The procedure was then completed with no adverse consequences to the patient.However, a clinically significant delay in procedure was noted.
 
Manufacturer Narrative
Additional information: d10, g4, h2, h3, h6, h8.Optical fibers 1-3 met specifications for optical properties.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.The cause of the reported communication issue remains unknown.
 
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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 Key10487364
MDR Text Key205466980
Report Number3005334138-2020-00392
Device Sequence Number1
Product Code OAE
UDI-Device Identifier05415067027641
UDI-Public05415067027641
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,health
Type of Report Initial,Followup
Report Date 01/04/2021
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 Expiration Date08/31/2021
Device Model NumberA-TCSE-DF
Device Catalogue NumberA-TCSE-DF
Device Lot Number7447711
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/19/2020
Initial Date FDA Received09/03/2020
Supplement Dates Manufacturer Received12/30/2020
Supplement Dates FDA Received01/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMPERE RF ABLATION GENERATOR; TACTICATH CONTACT FORCE CATHETER; AMPERE RF ABLATION GENERATOR; TACTICATH CONTACT FORCE CATHETER
Patient Outcome(s) Other;
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