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

Model Number	401904
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
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 entrapment could not be conclusively determined.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
• Common Device Name: 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
• Report Number: 2182269-2023-00012
• Device Sequence Number: 12093871
• Product Code: DRA
• UDI-Device Identifier: 05414734202534
• UDI-Public: 05414734202534
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown