MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) TRANSSEPTAL NEEDLE, BRK SERIES

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.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.Review of the device history record was not possible as the lot number is unknown.

Event Description

Related mfr number: 3005334138-2020-00588.During the procedure, when performing the transseptal puncture, advancement of the needle and of the sheath perforated the posterior wall of the left atrium into the pericardial space.When the sheath was removed to be exchanged, the patient experienced hypotension and bradycardia, and chest compressions were performed.An effusion was diagnosed via fluoroscopy, and a pericardiocentesis was performed to stabilize the patient.

Manufacturer Narrative

Correction: d3, g1.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica MN 1897- 4050; CS 1897-4050
• MDR Report Key: 10963044
• MDR Text Key: 220146328
• Report Number: 2182269-2020-00111
• Device Sequence Number: 1
• Product Code: DRC
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FAST-CATH INTRODUCER; FAST-CATH INTRODUCER
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 50