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

Model Number 401904

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  malfunction  

Event 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.

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.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
• Type of Device: 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: 18092711
• MDR Text Key: 327635432
• Report Number: 2182269-2023-00051
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202534
• UDI-Public: 05414734202534
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model 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
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1