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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
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
During the procedure, an unknown soft, floppy structure was noted at the tip of the catheter upon removal from the patient. The catheter was introduced to the right atrium via the groin and would not advance to the coronary sinus. Upon removal, a soft, floppy structure was observed at the tip of the catheter. The catheter was replaced to continue the procedure no adverse consequences to 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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key10777785
MDR Text Key214332397
Report Number2182269-2020-00095
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeBE
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 12/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number401582
Device Catalogue Number401582
Device Lot Number7451531
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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