MAUDE Adverse Event Report: ST. JUDE MEDICAL THERAPY¿ COOL FLEX¿ ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number A088015

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/25/2021

Event Type  malfunction  

Event Description

During the procedure, the tip of catheter was blocked by a blood clot and became unable to ablate.The catheter was replaced and the procedure was completed with no patient consequences.

Manufacturer Narrative

Additional information: d9, g3, g6, h2, h3, h6 one quadripolar, therapy cool flex irrigated ablation catheter was received for evaluation.The catheter met specifications for electrical testing.An occlusion was noted in the deflection area upon inserting a guidewire.The shaft was dissected revealing a twisted fluid lumen, consistent with the observed occlusion error.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the ablation and irrigation issues remains unknown.

• Brand Name: THERAPY¿ COOL FLEX¿ ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12646434
• MDR Text Key: 276886439
• Report Number: 2030404-2021-00064
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110016
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: A088015
• Device Lot Number: 6886189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2019
• 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