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

Model Number 401904

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/03/2023

Event Type  Injury  

Event Description

During insertion of the catheter, it became stuck in the atrium and the pull wires broke.A snare was used to removed the catheter.The catheter was retained by the customer.

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 entrapment could not be conclusively determined.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
• Type of Device: CATHETER, 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16550882
• MDR Text Key: 311371515
• Report Number: 2182269-2023-00012
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202534
• UDI-Public: 05414734202534
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401904
• Device Catalogue Number: 401904
• Device Lot Number: 8744969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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
• Patient Outcome(s): Other; Required Intervention