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

Model Number	401932
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the catheter became entangled requiring the use of a snare to successfully remove the catheter with no adverse consequences to the patient.At the beginning of the procedure in voxel mode, while placing the catheter, it became looped and caught and was difficult to unloop to remove.A snare was used to remove from the heart and the device was replaced to complete the procedure with no adverse consequences to the patient.The physician does not allege any performance issues or device malfunction with the catheter.
Additional Manufacturer Narrative
One 7f, duo-decapolar, super large curl, livewire ep catheter was received for evaluation.The catheter shaft was able to deflect when actuating the steering mechanism; however, the distal shaft did not meet specifications for curve shape due to bends in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the device entanglement remains unknown.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),
• 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: 17825851
• Report Number: 2182269-2023-00043
• Device Sequence Number: 2480698
• Product Code: DRA
• UDI-Device Identifier: 05414734202626
• UDI-Public: 05414734202626
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: 04/30/2026
• Device Model Number: 401932
• Device Lot Number: 9051586
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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 Age: 20 YR
• Patient Sex: Unknown