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

Model Number	A701159
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure, an obstruction was noted due to a clot.Upon closer inspection, it was determined that the irrigation valve was closed and liquid could not irrigate properly.This happened at the start of the procedure, without any radiofrequency ablation application performed.The catheter was removed and a new one was used to continue the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One quadripolar, uni-directional, curve j, flexibility ablation catheter was received for evaluation.Microscopic inspection revealed bls in the extension tube and throughout the length of the fluid lumen.An occlusion was noted 40.0¿ distal to the extension tube opening.The flow rate could not be measured and the catheter could not be primed due to the blood-like substance.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
After further review, the investigation coding was updated to investigation findings mechanical problem identified c07 : blockage identified c0708 and internal clarifying code ep - flow obstruction, fm/bls occluding irrigation c070800-002.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE J
• 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: 11311577
• Report Number: 3008452825-2021-00090
• Device Sequence Number: 2660748
• Product Code: OAD
• UDI-Device Identifier: 05415067011510
• UDI-Public: 05415067011510
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: A701159
• Device Catalogue Number: A701159
• Device Lot Number: 7441525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/09/2021; 08/21/2023
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/11/2021; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown