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
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/05/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Corrected information: h6.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE F
• Common Device Name: 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
• Report Number: 3008452825-2022-00087
• Device Sequence Number: 11914083
• Product Code: OAD
• UDI-Device Identifier: 05415067011503
• UDI-Public: 05415067011503
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2022
• Supplement Date Received by Manufacturer: 05/18/2022; 07/20/2023
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 05/23/2022; 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown