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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, the physician was unable to put the catheter into the coronary sinus because the catheter would not deflect as expected.The catheter was removed from the patient an unknown substance was noted to be attached to the distal end device.The catheter was exchanged and the procedure was completed with no adverse consequences to the patient.The catheter was not properly inspected by staff when it was opened but the sales rep suspects that tissue in the heart may have been accidentally caught by the catheter.The customer suspected that the substance shown in the picture is the catheter coating.
Additional Manufacturer Narrative
One 7f, duo-decapolar, super large curl, livewire ep catheter was received for evaluation.A foreign material on the returned device was found.The foreign material was noted to be a biological material in ftir spectrum analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the foreign material remains unknown.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19937659
• Report Number: 2182269-2024-00023
• Device Sequence Number: 15307154
• Product Code: DRA
• UDI-Device Identifier: 05414734202534
• UDI-Public: (01)05414734202534(10)10084057(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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 Model Number: 401904
• Device Catalogue Number: 401904
• Device Lot Number: 10084057
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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