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

Model Number	402022
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the paroxysmal supraventricular tachycardia procedure, noise issues resulting in multiple exchanges which caused procedural delays.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.The catheter was inserted into the heart and connected to the connecting cable but noise was noted on the electric potentials 1-2 and electric potential could not read.The connecting cable was exchanged with no resolution.The catheter was exchanged to a second one of same lot number with no resolution.The catheter was replaced to a third one and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: LIVEWIRE¿ STEERABLE ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, 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 Key: 17077734
• Report Number: 2182269-2023-00027
• Device Sequence Number: 6346272
• Product Code: DRA
• UDI-Device Identifier: 05414734202763
• UDI-Public: 05414734202763
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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: 05/31/2023
• Device Model Number: 402022
• Device Catalogue Number: 402022
• Device Lot Number: 7551959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown