MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TRANSSEPTAL NEEDLE, BRK SERIES; TROCAR

Model Number G407208

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

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

Event Date 01/13/2020

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

The following event was found during a search of the maude database performed on 29 april 2020, report number 2029046-2020-00203: it was reported that a male patient underwent a persistent atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis and surgical intervention), cardiac arrest (requiring cardiopulmonary resuscitation (cpr)) and death.At an unspecified stage during the procedure, bleeding was noticed and cardiac tamponade was confirmed.Pericardiocentesis was performed to drain the fluid from the pericardial space.The patient was then taken to surgery for a sternotomy to repair the wound.The patient went into cardiac arrest.Extracorporeal membrane oxygenation (ecmo) was attempted.However, it was not possible to be applied.Cpr was performed for 1.5 hours without success and the patient expired.Transseptal puncture was performed with a abbott brk needle.Physician's opinion regarding the cause of the adverse event was that it was patient condition and procedure related.

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.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• 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: 10060664
• MDR Text Key: 191082017
• Report Number: 3008452825-2020-00238
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• PMA/PMN Number: K122587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

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: 04/30/2022
• Device Model Number: G407208
• Device Lot Number: 7021905
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 06/19/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death