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

Model Number 402819

Device Problem Material Deformation (2976)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation 3d mapping procedure, signal interference was identified and the catheter was difficult to position in the patient.Upon removal from the patent, the electrode was noted to be separated from the shaft.Another device was used to continue this procedure and consequences to the patient.No additional information is available.

Manufacturer Narrative

One 4mm tip, medium sweep, safire ablation catheter was received for evaluation.The distal tip was noted to be separated from the distal tip.Bends were noted in the shaft at 1.5¿, 2.6¿ and 5.7¿ proximal to the distal tip.Functional testing revealed the catheter was able to deflect in both directions when actuating the steering mechanism.The shaft did not deflect into the correct shape in either direction and no longer met specifications due to the bends in the shaft.Electrodes 1-4 and the thermistor/thermocouple met specifications during electrical testing, temperature testing could not be completed due to aforementioned damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported displaced electrode could not be conclusively determined.

• 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, 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: 15798772
• MDR Text Key: 304992653
• Report Number: 2182269-2022-00061
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402819
• Device Lot Number: 8581080
• 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: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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