MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY ABLATION CATHETER, SENSOR ENABLED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A-FASE-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a redo pulmonary vein isolation and left atrial tachycardia procedure in the left atrium, a pericardial effusion occurred.During the procedure, the catheter made a crackling noise while bending and stretching.Because radio frequency ablation could be applied without any restriction, the catheter was not replaced and ablation was completed successfully with this catheter.At the end of the procedure, the patient became hypotensive and an ultrasound revealed a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with the device.
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 perforation remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Additional Manufacturer Narrative
Additional information: b5, d10.
Event or Problem Description
Related manufacturing ref: (b)(4).
Additional Manufacturer Narrative
One quadripolar, uni-directional, curve d, flexibility sensor enabled ablation catheter was received for evaluation.The catheter deflected when actuating the steering mechanism and the curve dimensions met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported effusion remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• Brand Name: FLEXABILITY ABLATION CATHETER, SENSOR ENABLED
• 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
• MDR Report Key: 11477832
• Report Number: 3008452825-2021-00150
• Device Sequence Number: 14271946
• Product Code: OAD
• UDI-Device Identifier: 05415067020031
• UDI-Public: 05415067020031
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2021

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: 07/31/2023
• Device Model Number: A-FASE-D
• Device Catalogue Number: A-FASE-D
• Device Lot Number: 7633340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/05/2021; 03/19/2021; 04/23/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/18/2021; 03/19/2021; 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRK TRANSSEPTAL NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention