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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL CATHETER, STEERABLE

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ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL CATHETER, STEERABLE Back to Search Results
Model Number 401908
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemothorax (1896); Cardiac Perforation (2513)
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report. Further information regarding the event was requested but not received.
 
Event Description
Related manufacturer reference: 3008452825-2020-00255, 3008452825-2020-00256, 3008452825-2020-00257, 2182269-2020-00051. During ventricular tachycardia mapping in the left ventricle, a pericardial effusion occurred. After approximately an hour of mapping, using transseptal approach, the patient became hypotensive. An ultrasound confirmed a pericardial effusion for which a pericardiocentesis was administered. An additional ultrasound confirmed a left hemothorax, which required a drain. The cause and location of the pericardial effusion remains unknown, however it was noted the transseptal puncture was difficult. The patient was stable with minimal use of catecholamines and transferred to the icu. There were no performance issues with any abbott device.
 
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Brand NameLIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
Manufacturer (Section G)
ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
14901 deveau place
minnetonka MN 55345
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key10098867
MDR Text Key193017208
Report Number2182269-2020-00050
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K022380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number401908
Device Catalogue Number401908
Device Lot Number7125108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2019
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: 05/28/2020 Patient Sequence Number: 1
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