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	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a redo pulmonary vein isolation and cti line procedure, the diagnostic catheter became stuck in the right atrium at the tip and around position of electrode 19-20.It is unknown what caused the entrapment.Due to manipulation the diagnostic catheter was bent 1cm proximal of electrode 19-20.The ablation catheter was then inserted to try to free the tip.This did not work so the sheath was advanced over the diagnostic catheter for more support.To do so the handle of the diagnostic catheter was cut and a suture was fixated to the end.This was done in order to use the sheath to slide over the diagnostic catheter for more support.The suture was used to extend the grip of the diagnostic catheter while sliding the sheath over the diagnostic catheter.The sheath and diagnostic catheter were then manipulated to free the catheter tip.Once the diagnostic catheter was freed, no tissue was seen at the tip of the catheter.The physician alleges that the catheter was entangled in the chordae of the tricuspid valve.A transesophageal echocardiogram showed there were no injuries.The procedure was terminated, and patient went back to the ward to be monitored.
Additional Manufacturer Narrative
One 7f, duo-decapolar, super large curl, livewire ep catheter was received for evaluation.The catheter shaft was cut from the handle and bent in multiple locations.Further, due to unknown procedural conditions and the aforementioned damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported entanglement remains unknown.

• 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: 18839478
• Report Number: 2182269-2024-00006
• Device Sequence Number: 20628442
• Product Code: DRF
• UDI-Device Identifier: 05414734202534
• UDI-Public: 05414734202534
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151622
• 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): 04/24/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 401904
• Device Lot Number: 10042317
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown