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

Model Number 402822

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)

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

Event Date 05/13/2023

Event Type  malfunction  

Event Description

During the supraventricular tachycardia procedure, display and noise issues with the catheter resulted in procedural delays.The device was replaced and the procedure was completed with no adverse consequences to the patient.The ablation catheter was inserted into the atrium.After the catheter was connected, the three-dimensional shape of the catheter was abnormal, and the potential could not be displayed.The connection was checked, he tail wire was replaced, and the ampere, the amplifier and the dws were all restarted, but the issue could not be resolved.The catheter was replaced with a new one and the procedure ended smoothly with no adverse patient consequences.

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 and display issue remains unknown.

Manufacturer Narrative

The results of the investigation concluded that electrodes 1-4 met specifications of acceptable resistance values with no open or short circuits detected.Bends were noted in the shaft at 0.6¿, 4.4¿ and 18.7¿ proximal to the distal tip.No other visual anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported noise and display issue 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: 17007869
• MDR Text Key: 316009198
• Report Number: 2182269-2023-00024
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960016/S014
• 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,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402822
• Device Lot Number: 8812150
• 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: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2023
• 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