MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH

Model Number G407211

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

The reported cardiac tamponade could not be confirmed.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.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturer report number: 9680001-2017-00103, 3008452825-2017-00328, 2030404-2017-00056.During an atrial tachycardia procedure, a cardiac tamponade occurred.After isolating the pulmonary veins with the ablation catheter the patient became hypotensive and an echocardiogram revealed a cardiac tamponade for which a pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7122080
• MDR Text Key: 94993537
• Report Number: 3008452825-2017-00327
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072278
• 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: 12/15/2017

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: 08/31/2020
• Device Model Number: G407211
• Device Lot Number: 6131068
• Other Device ID Number: 05414734205153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• 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
• Treatment: AGILIS NXT; INQUIRY AFOCUS II; TACTICATH QUARTZ
• Patient Outcome(s): Required Intervention