MAUDE Adverse Event Report: ST. JUDE MEDICAL LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL; CATHETER, STEERABLE

Model Number	401908
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a ventricular tachycardia (vt) procedure, it was noted an electrode was displaced on the catheter.The cable was exchanged and the pin location was changed with no resolution.The catheter was exchanged and the procedure completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6.One 7f, duo-decapolar, medium curl, livewire ep catheter was received for evaluation. microscopic investigation revealed no anomalies to the electrodes.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The reported displaced electrodes reported was not confirmed.

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 11677684
• Report Number: 2182269-2021-00031
• Device Sequence Number: 17045647
• Product Code: DRA
• UDI-Device Identifier: 05414734202558
• UDI-Public: 05414734202558
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 11/30/2023
• Device Model Number: 401908
• Device Catalogue Number: 401908
• Device Lot Number: 7762591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1