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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 401575
Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)
Patient Problem Cardiac Perforation (2513)
Event Date 04/22/2022
Event Type  Injury  
Event Description
Related manufacturing ref: 3008452825-2022-00407, 3008452825-2022-00408. During a supraventricular ablation procedure with wolfe parkinson white syndrome, a pericardial effusion was noted in the coronary sinus. During the procedure, electrode 7-8 of the steerable catheter showed noise and stretching on the system screen and the physicians involved stated high impedance was noted. The signals of cs 7-8 were hidden from both the ensite precision and the ep recording system to continue the procedure. Access the coronary sinus (cs) was attempted with the steerable catheter, and subsequently with the help of the sl3 sheath. A non abbott guidewire was then used to guide the cs catheter. After the catheters were in place, the study was performed. The patient then became restless and stats dropped to approximately 70+. An echo was then performed which revealed an effusion. However, the procedure was abandoned midway through the study as the patient experienced a pericardial effusion which was confirmed via echocardiogram. A pericardiocentesis was performed which stabilized the patient.
 
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Brand NameLIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
Type of DeviceCATHETER, STEERABLE
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
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key14306228
MDR Text Key294657449
Report Number2182269-2022-00026
Device Sequence Number1
Product Code DRA
UDI-Device Identifier05414734202183
UDI-Public05414734202183
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K022380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number401575
Device Catalogue Number401575
Device Lot Number8185167
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2021
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: 05/06/2022 Patient Sequence Number: 1
Treatment
SUPREME¿ EP CATHETER; SUPREME¿ EP CATHETER
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