MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F; INTRODUCER, CATHETER

Model Number 407439

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

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

Event Date 07/06/2020

Event Type  Death  

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.Based on the information received, the cause of the reported pericardial effusion and subsequent death may have been procedure related.

Event Description

During a left atrial appendage occlusion (laao) procedure, a pericardial effusion occurred and the patient expired.An sl1 introducer and reprocessed brk1 needle were used for transseptal puncture.Following a difficult transseptal puncture due to pacemaker probes in the right atrium, a pericardial effusion was noted via transesophageal echo and the patient became hemodynamically unstable.The procedure was abandoned immediately following transseptal puncture and a pericardiocentesis was performed due to low cardiac output.Cardiopulmonary reanimation was performed several times due to asystole / electromechanical disassociation.The patient was transferred to the intensive care unit and expired 2 hours post procedure.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F
• Type of Device: INTRODUCER, CATHETER
• 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: 10283080
• MDR Text Key: 199082487
• Report Number: 3005334138-2020-00290
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205634
• UDI-Public: 05414734205634
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 407439
• Device Catalogue Number: 407439
• Device Lot Number: 7528975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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): Required Intervention