MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial flutter procedure, positioning issues with the catheter required troubleshooting measures and resulted in the procedure being aborted with no adverse consequences to the patient.The catheter was introduced via right femoral access and positioned into the right atrium.Difficulty was noted when attempting to place the catheter tip into the coronary sinus.Attempts to place other catheters into the coronary sinus were also unsuccessful.An hour into the procedure, it was noted that the catheter was entangled in the right atrium.Different maneuvers were performed and the catheter was successfully removed.The procedure was aborted with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g1, g3, h2, h3, h6.One 7f, duo-decapolar, super large curl, livewire ep catheter was received for evaluation.The catheter shaft was found bent.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the device entanglement remains unknown.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
• 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: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18092711
• Report Number: 2182269-2023-00051
• Device Sequence Number: 12220152
• Product Code: DRA
• UDI-Device Identifier: 05414734202534
• UDI-Public: (01)05414734202534(10)8879912(17)260131
• 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,Followup
• Report Date (Section B): 07/22/2024

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: 01/31/2026
• Device Model Number: 401904
• Device Catalogue Number: 401904
• Device Lot Number: 8879912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 11/22/2023; Not provided
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/29/2023; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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