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-DF

Device Problem Insufficient Information (3190)

Patient Problem Cardiogenic Shock (2262)

Event Date 12/04/2020

Event Type  Injury  

Event Description

Related manufacturer ref: 2182269-2021-00020, 3005334138-2021-00131.The patient was admitted to the cardiovascular intensive care unit for vasopressor support of blood pressure for cardiogenic shock.Administration of the medications stabilized the patient.

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 cardiogenic shock could not be conclusively determined.

• 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; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11388702
• MDR Text Key: 240380347
• Report Number: 3005334138-2021-00087
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: (01)05415067020062(10)7131370(17)220731
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: A-FASE-DF
• Device Catalogue Number: A-FASE-DF
• Device Lot Number: 7131370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR HD GRID MAPPING CATHETER, SE; LIVEWIRE DIAGNOSTIC CATHETER
• Patient Outcome(s): Required Intervention