MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number G407212

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

Patient Problem Cardiac Perforation (2513)

Event Date 04/01/2019

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

Event Description

Related manufacturing ref: 3005334138-2019-00217, 3008452825-2019-00190, 3008452825-2019-00191, 3008452825-2019-00193, 3008452825-2019-00194, 3005334138-2019-00218, 3005334138-2019-00219.During a ventricular tachycardia procedure, a cardiac tamponade occurred.Several minutes after ablating the right ventricle, the patient became hypotensive.Transesophageal echography revealed a tamponade.A thoracotomy was performed to stabilize the patient.There were no performance issues with any abbott device.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: TROCAR
• 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: 8533277
• MDR Text Key: 142547821
• Report Number: 3008452825-2019-00192
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205191
• UDI-Public: 05414734205191
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K122587
• 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: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: G407212
• Device Lot Number: 6869062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• 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¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
• Patient Outcome(s): Required Intervention