MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; ELECTRODE RECORDING CATHETER

Model Number 401940

Device Problem Signal Artifact/Noise (1036)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

Related manufacture ref: (b)(4).During wolfe parkinson white (wpw) procedure, distortion was noted on electrode 2 of the catheter.A second catheter from the same lot was used and the same issue was noted on electrode 9.The cables were replaced and ampere inputs were changed with no resolution.A third catheter was used to complete the procedure with no consequences to the patient.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One 5f, decapolar, medium sweep, livewire ep catheter was received for evaluation.Electrode ring 9 was dissected to reveal that conductor wire 9 was fractured proximal to the weld joint, consistent with the open circuit detected and the reported noise.Electrodes 1-2 and 10 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wire and subsequent delay remains unknown.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Type of Device: ELECTRODE RECORDING CATHETER
• 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: 17171866
• MDR Text Key: 317564527
• Report Number: 2182269-2023-00028
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202688
• UDI-Public: 05414734202688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401940
• Device Catalogue Number: 401940
• Device Lot Number: 8855337
• 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: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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
• Treatment: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER.
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White