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.

Manufacturer Narrative

One 4mm tip, large curl, safire ablation catheter was received for evaluation.The results of the investigation concluded that electrodes 1-4 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 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: 19205572
• MDR Text Key: 341364338
• Report Number: 2182269-2024-00010
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05414734206020
• UDI-Public: (01)05414734206020(10)10016473(17)260930
• 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: 10016473
• 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
• Date Device Manufactured: 10/03/2023
• 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: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER
• Patient Sex: Female