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 Problem Complete Heart Block (2627)

Event Date 10/02/2020

Event Type  Injury  

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 incident could not be conclusively determined.

Event Description

During a vt ablation procedure, a complete heart block occurred.The patient already had a rbbb and underwent an icd implant procedure.While ablating in the endocardial surface of the left ventricle, the left bundle branch block (lbbb) was observed and was confirmed via echocardiogram.The mean rate of the defibrillator was increased to stabilized the patient and the procedure was completed with no adverse patient consequences.There were no performance issues with any abbott devices.

• 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: 10732973
• MDR Text Key: 212969697
• Report Number: 3008452825-2020-00533
• 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
• Report Date: 10/26/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: A-FASE-D
• Device Catalogue Number: A-FASE-D
• Device Lot Number: 7596090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• 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): Required Intervention
• Patient Age: 57 YR