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

Model Number G407212

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

Patient Problems Cardiac Perforation (2513); Vascular Dissection (3160)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing ref: 3008452825-2020-00321, 3008452825-2020-00322.During a persistent atrial fibrillation ablation procedure, a cardiac tamponade and dissection occurred.Difficulty was noted during catheterization of the vein of marshall and a coronary sinus dissection occurred.When applying the 4th rf application on the mitral isthmus, the patient¿s blood pressure collapsed and an echocardiogram revealed a cardiac tamponade.A pericardiocentesis was performed, however the patient was unstable.There were no performance issues with any abbott devices.

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 remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

Manufacturer Narrative

Correction: h6 health impact code.Additional information: h6 component code.

• Brand Name: BRK-1 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
• MDR Report Key: 10190081
• MDR Text Key: 196774975
• Report Number: 3008452825-2020-00323
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205191
• UDI-Public: 05414734205191
• Combination Product (y/n): N
• PMA/PMN Number: K122587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: G407212
• Device Catalogue Number: G407212
• Device Lot Number: 7125278
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS¿ NXT STEERABLE INTRODUCER; TACTICATH¿ ABLATION CATHETER, SE
• Patient Outcome(s): Required Intervention