MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	A701125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	06/20/2023
Type of Reportable Event	Death
Event or Problem Description
During a left ventricular end systolic volume procedure, the patient became hemodynamically unstable, and expired.After mapping the left ventricle and radiofrequency applications without interruption of the arrhythmia, a new map was completed.During this hemodynamic instability was observed including bradycardia, hypertension, and sweating.The hemodynamicists was called in, cardiac catheterization was performed, angioplasty with implantation of two stents, cardiac compression was started, and shock was delivered, without success.There were no alleged performance issues with any abbott products and it is unknown what caused the patient to become unstable.
Additional 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 arrhythmia remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 17538234
• Report Number: 3008452825-2023-00342
• Device Sequence Number: 6101287
• Product Code: OAD
• UDI-Device Identifier: 05415067011114
• UDI-Public: 05415067011114
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 09/13/2023

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: 03/31/2025
• Device Model Number: A701125
• Device Lot Number: 8453671
• Was Device Available for Evaluation?: No
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/13/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2022
• 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
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Unknown