MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number A701158

Device Problems Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/05/2022

Event Type  malfunction  

Event Description

During the premature ventricular contractions procedure, the heparinized saline was temporarily stopped and about ten minutes later, the catheter was blocked by a blood clot when tried to refill it with heparinized saline.When the catheter was taken out of the patient, the fluid did not come out through quick flushing with infusion pump and direct injection with syringe.The catheter was exchanged and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One quadripolar, uni-directional, curve f, flexability ablation catheter was received for evaluation.A blood-like substance was noted to be obstructing the fluid lumen, consistent with the irrigation issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the irrigation occlusion is consistent with damage during use.

Manufacturer Narrative

Corrected information: h6.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE F
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13734575
• MDR Text Key: 287273554
• Report Number: 3008452825-2022-00087
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067011503
• UDI-Public: 05415067011503
• 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: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A701158
• Device Catalogue Number: A701158
• Device Lot Number: 8034015
• 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: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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