MAUDE Adverse Event Report: ST. JUDE MEDICAL SAFIRE TX BI-DIRECTIONAL ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONIT; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 402840

Device Problem Failure to Analyze Signal (1539)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During an av node ablation procedure, signal did not appear for the ablation catheter.The catheter was exchanged with no success.Tech support was called, and the issue remained after checking the cables and connections.The catheter was exchanged with a non-abbott catheter to complete the procedure with no adverse patient consequences.However, there was a 45 minute delay due to the issue.

• Brand Name: SAFIRE TX BI-DIRECTIONAL ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONIT
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10669278
• MDR Text Key: 211018350
• Report Number: 2030404-2020-00089
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05414734300162
• UDI-Public: 05414734300162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 402840
• Device Catalogue Number: 402840
• Device Lot Number: 7410560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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
• Patient Outcome(s): Other