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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER CATHETER, STEERABLE

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ST. JUDE MEDICAL LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER CATHETER, STEERABLE Back to Search Results
Model Number 402032
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
One 6f, duo-decapolar, large curl, livewire ep catheter was received for evaluation. Electrodes 1-2, 9-10, and 13-14 displayed acceptable resistance values; however, a short circuit was detected between electrode 1 and conductor wire 13. Dissection revealed that the flat wire insulation was torn and the insulation for conductor wire 13 was abraded in the same location, consistent with the short circuit detected and the reported noise. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The cause of the short circuit is consistent with damage during use.
 
Event Description
This report is to advise of an event observed during analysis confirming a short circuit.
 
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Brand NameLIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
14901 deveau place
minnetonka MN 55345
Manufacturer (Section G)
ST. JUDE MEDICAL
14901 deveau place
minnetonka MN 55345
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key11311250
MDR Text Key231395190
Report Number2182269-2021-00010
Device Sequence Number1
Product Code DRA
UDI-Device Identifier05414734202817
UDI-Public05414734202817
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number402032
Device Catalogue Number402032
Device Lot Number7442125
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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