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

Model Number 402022

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 316879842
• Report Number: 2182269-2023-00027
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202763
• UDI-Public: 05414734202763
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1