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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. AGILIS¿ INTRODUCER, UNKNOWN Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Stroke/CVA (1770); Paralysis (1997); Cardiac Perforation (2513)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: swartz¿ introducer, livewire¿ ep catheter, flexibility ablation catheter. The results of the investigation are inconclusive since the device was not returned for analysis. Review of the device history record was not possible as the lot number is unknown. Based on the information received, the cause of the reported incidents remain unknown.
 
Event Description
Related manufacturing ref: 3005334138-2019-00466, 2182269-2019-00124, 3005334138-2019-00467. The following was published in the heart rhythm. 2018;15(1):65-74 titled: incidence and significance of adhesions encountered during epicardial mapping and ablation of ventricular tachycardia in patients with no history of prior cardiac surgery or pericarditis. "a retrospective search of our ablation database containing patients who underwent epicardial ablation for vt was undertaken. Adhesions were diagnosed with routine contrast pericardiography after pericardial entry. Demographics and longterm outcomes were compared between patients with and without adhesions. The participants in this study comprised consecutive patients of age (b)(6) years who underwent catheter ablation of ventricular tachycardia (vt) via percutaneous epicardial access. Exclusion criteria were documented prior cardiac surgery or those with a prior history of clinical pericarditis. The etiology of structural heart disease was established according to conventional diagnostic criteria, and patients were imaged preprocedurally with cardiac magnetic resonance imaging or transthoracic echocardiography or both. Where possible, antiarrhythmic drug therapy was withdrawn 5 half-lives prior to the procedure except in those patients on amiodarone. During the procedure, tamponade occurred in 6 patients, 1 patient had av block, 2 patients had transient phrenic nerve palsy, 1 patient had cerebrovascular accident (cva). Post procedure, 8 patients had heart failure or cardiogenic shock.
 
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Brand NameAGILIS¿ INTRODUCER, UNKNOWN
Type of DeviceINTRODUCER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8942296
MDR Text Key156405553
Report Number2182269-2019-00123
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 literature
Reporter Occupation
Type of Report Initial
Report Date 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
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
Event Location No Information
Date Manufacturer Received08/21/2019
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: 08/28/2019 Patient Sequence Number: 1
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