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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), SUPER LARGE CATHETER, STEERABLE

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ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE CATHETER, STEERABLE Back to Search Results
Model Number 401904
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  Injury  
Event Description
During a supraventricular tachycardia ablation procedure, the catheter became bent and a snare was needed to remove the device. The catheter was placed into the right atrium, the actuator handle was turned to place into the device into the coronary sinus (cs). The physician stated the patients atrium was normal size and he was having difficulties cannulating the cs. An attempt to straighten the curve of the catheter was unsuccessful. The device was able to be rotated 360 degrees without resistance. The catheter could not be advanced into the svc, ivc, or rv, when attempting to straighten and remove the catheter. After attempting to remove the catheter for approximately 30 minutes, a snare was placed into the right atrium and attached to the distal portion of the catheter. While holding the distal portion stable, the catheter was able to be removed. The catheter was replaced with a device from the same model with no consequences to the patient.
 
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Brand NameLIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
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 Key13011834
MDR Text Key282287028
Report Number2182269-2021-00092
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number401904
Device Catalogue Number401904
Device Lot Number7963883
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2021
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: 12/15/2021 Patient Sequence Number: 1
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