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

Model Number 407201

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

Patient Problem Cardiac Perforation (2513)

Event Date 08/22/2019

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 cardiac perforation may have been procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

During a pulmonary vein isolation ablation procedure, a pericardial effusion occurred.The transseptal puncture was noted to be difficult and the guidewire was seen to advance into the pericardial space on fluoroscopy and echocardiogram.Contrast was injected and moderate staining in the superior pericardium was seen.The patient remained stable and no intervention was required but the procedure was cancelled.There were no performance issues with any abbott device.

• Brand Name: BRK-1¿ TRANSSEPTAL NEEDLE, 71 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: 8950721
• MDR Text Key: 156134298
• Report Number: 3008452825-2019-00433
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 7015657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2019
• 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
• Patient Outcome(s): Required Intervention