MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TRANSSEPTAL NEEDLE, BRK SERIES

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

Patient Problem Cardiac Perforation (2513)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was impossible due to device lot number being unknown.Based on the information received, the cause of the reported incident remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturing ref: 9680001-2019-00012, 2182269-2019-00012.During ablation in the left atrium, a pericardial effusion occurred in the anterior septum.A pericardiocentesis was performed and surgery was required to stabilize the patient.There were no performance issues with any abbott devices.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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, COSTA RICA LTDA; 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: 8333347
• MDR Text Key: 135991499
• Report Number: 3008452825-2019-00056
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 95