MAUDE Adverse Event Report: ST. JUDE MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES

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

Patient Problems Cardiac Perforation (2513); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  Death  

Event Description

During the mitraclip procedure, a pericardial effusion occurred, and the patient expired.The guide was inserted into the left ventricle, and the wire into the pulmonary vein.The guide was then centered in the left atrium, and while the wire was pulled back into the guide under aspiration, the blood pressure dropped without any sight of a pericardial effusion.In this moment, cpr was performed, and the guide was pulled back in the right atrium.At this moment the hemoglobin (hb) dropped from 9g/dl before the procedure to 7.2 g/dl.Meanwhile cpr was continued, and in the echocardiogram a small pericardial effusion was seen.The pericardium was punctured, 40ml, cpr continued over 25 minutes without own blood pressure.The hb dropped to 4.6 g/dl.After 30 minutes of cpr without success, the patient was pronounced dead.The patient had a gastrointestinal hemorrhage before the procedure, and transseptal puncture was suboptimal due to challenging anatomy and the pacemaker lead being in the right atrium.It is unknown what caused the pericardial effusion.

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 perforation remains unknown.After further review, this event was reported by abbott under 2135147-2024-00125-00 and the brk needle was determined to be not associated with this event.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18481203
• MDR Text Key: 332488671
• Report Number: 3008452825-2024-00015
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death