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

Model Number	A701128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for investigation. the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott, the reported cardiac effusion could not be confirmed.Per the ifu, cardiac perforation is a known risk during the use of this device.Further information regarding the event were requested but not received.
Event or Problem Description
Related manufacturer reference: 2182269-2019-00064, 3008452825-2019-00243, 2182269-2019-00065, 2182269-2019-00066.During an atrial fibrillation ablation procedure, a cardiac effusion occurred.During ablation of the cavotricuspid isthmus (cti), a potential steam pop occurred, however it could not be confirmed.The procedure was able to be completed.Following the procedure, the patient became hypotensive.Intra-cardiac echocardiography(ice) confirmed an effusion for which a pericardiocentesis was performed to stabilize the patient.There were no performance issues with the abbott device.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE F-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
• MDR Report Key: 8631871
• Report Number: 3008452825-2019-00239
• Device Sequence Number: 19243396
• Product Code: OAD
• UDI-Device Identifier: 05415067011145
• UDI-Public: 05415067011145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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: 12/31/2021
• Device Model Number: A701128
• Device Catalogue Number: A701128
• Device Lot Number: 6792517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/22/2019
• 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: AGILIS¿ NXT STEERABLE INTRODUCER (X2); LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER (X2)
• Outcome Attributed to Adverse Event: Required Intervention