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

Model Number 407201

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

No product was returned for investigation. the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott, the reported tamponade could not be confirmed.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturer reference: 9680001-2018-00185, 3005334138-2018-00503.During a pulmonary vein isolation ablation procedure, a pericardial tamponade occurred.Following ablation on the left pv and movement and waking of the patient, the patient became hypotensive.An echocardiogram confirmed a pericardial tamponade on the left atrial appendage, for which a pericardiocentesis was performed.The patient was transported to the or for surgery and was successfully treated and stabilized.It was indicated the tamponade occurred due to a complicated transseptal puncture and a non-anesthesia procedure with a lot of patient movement.There were no performance issues with any abbott device during the procedure.

• Brand Name: BRK-1¿ TRANSSEPTAL NEEDLE, 71 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, COSTA RICA LTDA (AFD); 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: 8171798
• MDR Text Key: 130611909
• Report Number: 3008452825-2018-00428
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 6543798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2018
• 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): Other; Required Intervention