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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, MEDIUM CURL, 8.5 F INTRODUCER, CATHETER

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ST. JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, MEDIUM CURL, 8.5 F INTRODUCER, CATHETER Back to Search Results
Model Number 408310
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Cardiac Perforation (2513)
Event Date 09/23/2021
Event Type  Injury  
Event Description
Related manufacturing ref: 3005334138-2021-00617. During a paroxysmal atrial fibrillation procedure, a perforation occurred during ablation of the left atrial appendage/superior pulmonary vein ridge. The patient experienced increased heart rate, blood pressure, and st elevation. An ice catheter confirmed a perforation resulted in a pericardial effusion and eventual sternotomy. The physician believes that the tacticath se and rigidness of the agilis nxt sheath contributed to the perforation.
 
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Brand NameAGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, MEDIUM CURL, 8.5 F
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 Key12549938
MDR Text Key273892160
Report Number3008452825-2021-00465
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number408310
Device Catalogue Number408310
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/11/2021
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: 09/29/2021 Patient Sequence Number: 1
Treatment
TACTICATH ABLATION CATHETER, SE
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