MAUDE Adverse Event Report: ST. JUDE MEDICAL SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI; Cardiac ablation percutaneous catheter

Model Number 402811

Device Problem Signal Artifact/Noise (1036)

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

Event Date 04/09/2024

Event Type  malfunction  

Event Description

During an atrioventricular nodal reentrant tachycardia procedure, it was noted that there was noise on the safire bi-directional ablation catheter.The cable was replaced twice but with no resolution.The safire bi-directional ablation catheter was exchanged but noise was also noted on the second safire bi-directional ablation catheter.The second safire bi-directional ablation catheter was exchanged for tactiflex se ablation catheter and the procedure was able to be completed with no adverse consequences to the patient.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI
• Type of Device: Cardiac ablation percutaneous catheter
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19205618
• MDR Text Key: 341365392
• Report Number: 2182269-2024-00011
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960016
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402811
• Device Lot Number: 100111084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER
• Patient Sex: Female