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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS¿ INTRODUCER, UNKNOWN INTRODUCER, CATHETER

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ST. JUDE MEDICAL AGILIS¿ INTRODUCER, UNKNOWN INTRODUCER, CATHETER Back to Search Results
Device Problem Gas/Air Leak (2946)
Patient Problems Air Embolism (1697); Arrhythmia (1721)
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported air leak could not be conclusively determined.
 
Event Description
Related manufacturing ref: 3005334138-2022-00474. The physician reported transient st elevation occurred during a procedure. A single transseptal approach was used, and while changing between the tacticath se and the advisor hd, transient st elevation occurred while using the agilis introducer. The physician believes the st elevation was due to air entry between changes. The st elevation self-resolved and the procedure was completed with no patient consequences. No further information is available. Following the episode the physician started manually increasing the flow of the hd grid during exchanges by squeezing the chamber and has had no further episodes.
 
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Brand NameAGILIS¿ INTRODUCER, UNKNOWN
Type of DeviceINTRODUCER, CATHETER
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
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key15276712
MDR Text Key298414554
Report Number3008452825-2022-00554
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/23/2022 Patient Sequence Number: 1
Treatment
TACTICATH SENSOR ENABLED CATHETER
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