MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 & 8 MM TIP UNIVERSAL TEMPERATURE MONI; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 402823

Device Problem Signal Artifact/Noise (1036)

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

Event Date 05/15/2023

Event Type  malfunction  

Event Description

During the atrioventricular nodal reentrant tachycardia surgery, noise issues resulted in procedural delays.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.After connecting the catheter to the system, abnormal catheter morphologic display was observed with no potential at electrodes 1 and 2.The wiring was examined, the radiofrequency instrument was restarted, and the system was restarted, but the issue was not resolved.The catheter was replaced and the procedure was completed without adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation concluded that electrodes 1-2 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 reported noise remains unknown.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 & 8 MM TIP UNIVERSAL TEMPERATURE MONI
• Type of Device: CARDIAC ABLATION PERCUTANEOUS 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: 16942614
• MDR Text Key: 315336590
• Report Number: 2182269-2023-00023
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402823
• Device Lot Number: 8867689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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