MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

Model Number G407209

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

Patient Problems Cardiac Arrest (1762); Cardiac Perforation (2513)

Event Date 03/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactisys quartz system were returned.Review of the log files revealed the device functioned as intended and there were no contributing anomalies.Force measurements were recorded during ablation that exceeded the recommended values in the instructions for use (ifu); however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported event.The device history record was reviewed to ensure that each manufacturing and inspection with sjm specifications and procedures.The cause of the reported cardiac arrest and perforation may have been procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturing reference 9680001-2017-00023.During a pulmonary vein ablation procedure, the patient went into cardiac arrest and a tamponade was noted.During ablation of the right pulmonary veins, the patient became hypotensive and went into cardiac arrest.An ultrasound was performed which revealed a cardiac tamponade.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any sjm devices.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6447130
• MDR Text Key: 71294105
• Report Number: 3008452825-2017-00064
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/17/2017

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: 11/30/2019
• Device Model Number: G407209
• Device Lot Number: 5785463
• Other Device ID Number: 05414734205092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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: ADVISOR FL SENSOR ENABLED CATHETER; AGILIS NXT GUIDING INTRODUCER; ENSITE PRECISION SURFACE ELECTRODE KIT; SWARTZ TRANSSEPTAL INTRODUCER; TACTICATH ABLATION CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 56