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 402810

Device Problem Signal Artifact/Noise (1036)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

Related manufacturing ref: 2182269-2021-00095.During an atrioventricular nodal reentrant tachycardia (avnrt) slow pathway ablation procedure, noise was noted on the catheter.The cables, amplifier and catheter were exchanged with no resolution.Another catheter was used to complete the procedure with no consequences to the patient.

Manufacturer Narrative

One 4mm tip, medium 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 signal issue and subsequent delay remain 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, 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: 13095132
• MDR Text Key: 282827543
• Report Number: 2182269-2021-00096
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05414734206013
• UDI-Public: 05414734206013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960016-S014
• 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,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402810
• Device Catalogue Number: 402810
• Device Lot Number: 7994645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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