MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ INTRODUCER, UNKNOWN; TRANSSEPTAL CATHETER INTRODUCER

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

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

Event Date 11/22/2019

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

Related manufacturer reference number: 3008452825-2020-00239, 3008452825-2020-00240.The following event was found during a search of the maude database performed on 29 april 2020, report number: 2029046-2019-04029: it was reported that a male patient, underwent atrial fibrillation (afib) ablation procedure with thermocool smart touch sf bi-directional navigation catheter and suffered a cardiac tamponade and cardiac arrest resulting in surgical intervention and death.Patient came for a premature ventricular contraction (pvc) ablation with pre-existing bi-ventricular pacemaker.Ejection fraction was unknown.Transseptal was performed to access lv through the mitral valve.Case was completed and there was no mention of reduced blood pressure during the case.There were no concerns regarding product or product issues noted during the case.With removal of catheters and awakening from anesthesia, it was noted that the patient had a reduced blood pressure.Echocardiogram then demonstrated a pericardial effusion.Pericardiocentesis was performed and 500 ml of blood was removed.At this time, despite pacing, myocardium was not contracting.Resuscitative efforts were performed including chest compressions and use of epinephrine.Patient was placed onto ecmo and after approximately 90 minutes, patient was transferred to the operating room.A tear was noted in the aorta.No product was used in the aorta and the tear most likely occurred with transseptal procedure.After repair, there was still limited cardiac function and the patient expired an hour or so after surgery.Physicians opinion of cause is because of the transseptal during procedure.

• Brand Name: SWARTZ¿ INTRODUCER, UNKNOWN
• Type of Device: TRANSSEPTAL CATHETER INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10060659
• MDR Text Key: 191082151
• Report Number: 3005334138-2020-00191
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• 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
• Date Manufacturer Received: 04/29/2020
• 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
• Treatment: AGILIS INTRODUCER; BRK TRANSSEPTAL NEEDLE
• Patient Outcome(s): Death