MAUDE Adverse Event Report: ST. JUDE MEDICAL LIVEWIRE¿ TC ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP; CATHETER, PERCUTANEOUS CARDIAC ABLATION

Model Number 402115

Device Problem Signal Artifact/Noise (1036)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

Related manufacturing ref: 3005334138-2022-00284.During an atrioventricular nodal reentrant procedure, noise was noted when the catheter was connected to the generator.The catheter was exchanged with no resolution.A third catheter was used to complete the procedure with no consequences to the patient.

Manufacturer Narrative

Corrected information: additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is 2182269.One 7f, quadripolar, large curl, xls livewire tc ablation catheter was received for evaluation.Electrode 1 read as an open circuit.The shaft material just proximal to electrode 1 was dissected to reveal that conductor wire 1 was fractured proximal to the weld joint, consistent with the open circuit detected and the reported signal issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the signal issue was due to a fractured conductor wire, however the cause of the fractured wire remains unknown.

• Brand Name: LIVEWIRE¿ TC ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP
• Type of Device: CATHETER, PERCUTANEOUS CARDIAC ABLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14021735
• MDR Text Key: 288681466
• Report Number: 3005334138-2022-00283
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P960016
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 402115
• Device Lot Number: 7712804
• 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: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• 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¿ TC ABLATION CATHETER