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 Cardiac Arrest (1762); Cardiac Perforation (2513)

Event Date 02/22/2019

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 perforation and subsequent cardiac arrest 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: 3008452825-2019-00110.During a stand alone atrial appendage occlusion procedure, a cardiac perforation and subsequent cardiac arrest occurred.The procedure was performed under general anaesthetic with transesophageal echocardiogram guidance.Following the procedure, the tamponade was treated with a pericardiocentesis followed by emergency surgery.During surgery the location of the perforation was discovered in the pulmonary artery.During recovery, the patient experienced cardiac arrest.Following the cardiac arrest, brain infarcts were diagnosed by ct and upper arm weakness was noted.It was indicated the perforation occurred during the transseptal puncture.There were no performance issues with any abbott devices.

Event Description

The patient was discharged in a stable condition.The patient experienced residual weakness and lack of co-ordination with hands, however otherwise was fully recovered.

• Brand Name: SWARTZ¿ INTRODUCER, UNKNOWN
• Type of Device: TRANSSEPTAL CATHETER INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8429011
• MDR Text Key: 139084008
• Report Number: 3005334138-2019-00143
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K052644
• 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: 03/29/2019

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: 02/22/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSSEPTAL NEEDLE, BRK SERIES; TRANSSEPTAL NEEDLE, BRK SERIES
• Patient Outcome(s): Other; Required Intervention