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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 Electrical Shorting (2926)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned due to a contact force issue.Contact force was displayed when connected to the tactisys unit, with no error messages noted.The device met specifications for optical signal properties and the deformable body thermocouple met specifications during electrical testing; however, multiple short circuits were detected, consistent with the reported contact force issue.Fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle.In addition, dried saline was noted within the connector plug, consistent with the short circuits detected.No leaks were identified during leak testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detected saline in the catheter and fluid within the tygon tubing remains unknown.
 
Event Description
This report is to advise of an event observed during analysis, confirming a short circuit and leak within the catheter.
 
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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
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS  1897-4050
Manufacturer (Section G)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS   1897-4050
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key10441679
MDR Text Key204019769
Report Number3008452825-2020-00395
Device Sequence Number1
Product Code OAE
UDI-Device Identifier05415067027641
UDI-Public05415067027641
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P130026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2021
Device Model NumberA-TCSE-DF
Device Catalogue NumberA-TCSE-DF
Device Lot Number7351160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/05/2020
Initial Date FDA Received08/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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