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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cardiogenic Shock (2262); Cardiac Perforation (2513)

Event Date 12/12/2018

Event Type  Death  

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 pericardial effusion and subsequent patient expiration could not be conclusively determined.

Event Description

Following a ventricular tachycardia procedure, the patient expired.A small effusion was noted via transthoracic echocardiography following the procedure.No hemodynamic instability was noted and no intervention was required to treat the effusion.On (b)(6), the patient had expired due to multiorgan failure caused by refractory cardiogenic shock.There were no performance issues with any abbott device.

Event Description

Following a ventricular tachycardia procedure, the patient expired.A small effusion was noted via transthoracic echocardiography following the procedure.The patient became hemodynamically unstable and an intra-cardiac balloon and inotropic agents were used for mechanical support.Following the procedure, an intramyocardial hematoma was evident and a pericardial effusion was observed.Despite the hemodynamic support, the patient's condition worsened, leading to multiorgan failure caused by refractory cardiogenic shock.On (b)(6), the patient had expired due to their comorbidities.There were no performance issues with any abbott device.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8191024
• MDR Text Key: 131202206
• Report Number: 3008452825-2018-00430
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067020031
• UDI-Public: 05415067020031
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: A-FASE-D
• Device Lot Number: 6265383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death