MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number 407200

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

Patient Problems Death (1802); Cardiac Perforation (2513)

Event Date 07/25/2020

Event Type  Death  

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.Further information regarding the event was requested but not received.

Event Description

Related manufacturer reference: 3005334138-2020-00362, 3008452825-2020-00416.During a ventricular tachycardia ablation procedure, a cardiac tamponade occurred.Following the transseptal puncture, when attempting the retro aortic technique, a cardiac tamponade was observed.The tamponade was confirmed by echocardiogram located at the left atrial appendage.It is unknown which device caused the tamponade.Defibrillation, cardiac massage and cardiac surgery were performed to treat the patient.The patient expired due to instable hemodynamics.There were no performance issues with any abbott device.

Event Description

During a ventricular tachycardia ablation procedure, a cardiac tamponade occurred.A transseptal puncture was performed using guided intracardiac echocardiogram and a transesophageal echocardiogram due to anatomical changes in the interatrial septum (hypertrophy).Difficulty was noted maneuvering through the left atrium to the left ventricular with the flexability catheter and the md opted to use a retrograde approach.During this approach, a cardiac tamponade was diagnosed by echocardiogram requiring at thoracotomy for drainage.The patient experienced severe hemorrhagic shock, severe systemic dysfunction refractory to measures of blood products, vasoactive drugs and intra-aortic balloon pump resulting in death.It was unknown when the perforation occurred, or which device caused the tamponade.There were no performance issues with any abbott device.

• Brand Name: BRK TRANSSEPTAL NEEDLE, 71 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
• MDR Report Key: 10430841
• MDR Text Key: 203659235
• Report Number: 3008452825-2020-00417
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: 05414734205092
• Combination Product (y/n): N
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 7159278
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXABILITY ABLATION CATHETER, BI-D, CURVE F-J; SWARTZ BRAIDED TRANSSEPTAL INTRODUCER; FLEXABILITY ABLATION CATHETER, BI-D, CURVE F-J; SWARTZ BRAIDED TRANSSEPTAL INTRODUCER
• Patient Outcome(s): Death