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

Model Number	402032
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
This report is to advise of an event observed during analysis confirming a short circuit.

• Brand Name: LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 11311250
• Report Number: 2182269-2021-00010
• Device Sequence Number: 3302589
• Product Code: DRA
• UDI-Device Identifier: 05414734202817
• UDI-Public: 05414734202817
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 402032
• Device Catalogue Number: 402032
• Device Lot Number: 7442125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1