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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE
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ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE Back to Search Results
Model Number 401582
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 10/22/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Manufacturing related ref: 3008452825-2019-00572, 3005334138-2019-00622.During the ventricular tachycardia ablation procedure near the left apex of the left ventricular, a pericardial effusion occurred.At the end of the procedure, the patient became hypotensive, and bradycardia was exhibited.Pacing was performed and the blood pressure was 80/60.After three minutes, the patient became hypotensive again so an echocardiography was performed showing a pericardial effusion requiring a pericardiocentesis.The patient was transferred to the ccu unit and will be monitored.
 
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
 
Event or Problem Description
The patient was discharged the following day.
 
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Brand Name
LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
Common Device Name
CATHETER, STEERABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
MDR Report Key9310761
Report Number2182269-2019-00239
Device Sequence Number2131766
Product Code DRA
UDI-Device Identifier05414734202251
UDI-Public05414734202251
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K913940
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/12/2019
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
Operator of Device Health Professional
Device Expiration Date05/31/2022
Device Model Number401582
Device Catalogue Number401582
Device Lot Number6989575
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/22/2019
Supplement Date Received by Manufacturer11/13/2019
Initial Report FDA Received Date11/12/2019
Supplement Report FDA Received Date12/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ADVISOR HD 16 ELECTRODE DF BI-D OUS; TACTICATH SE CATHETER, UNI-D, CURVE F
Outcome Attributed to Adverse Event Other; Required Intervention;
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