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

Model Number G407211

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

Patient Problem Cardiac Perforation (2513)

Event Date 10/08/2019

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

Event Description

Related manufacturing reference: 3008452825-2019-00538.During an atrial fibrillation ablation procedure a pericardial effusion occurred.Following the completion of the left sided ablation the patient became hypotensive.A pericardial effusion was confirmed by echocardiography and a pericardiocentesis was performed to stabilize the patient.Once blood pressure was stabilized the patient was transferred to cardiac surgery to repair the perforation.The ablation procedure was not completed and there were no performance issues with any abbott device.The user stated the perforation occurred during transseptal puncture with the brk needle.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: TROCAR
• 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: 9249736
• MDR Text Key: 164099417
• Report Number: 3008452825-2019-00537
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: 05414734205153
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/29/2019

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
• Device Expiration Date: 07/31/2020
• Device Model Number: G407211
• Device Lot Number: 6086887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2017
• 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: BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 92