MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number 407453

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

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

Event Date 11/16/2020

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 incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

During the ventricular tachycardia ablation procedure, the patient had a cardiac perforation and subsequently died.An hd grid was inserted through a sl1 introducer.A transseptal puncture was performed using a non-abbott guidewire and the sheath passed successfully into what was believed to be the left pulmonary vein, although the location was not certain after switching the guidewires out for the sheath.Resistance was felt while trying to cross into the mitral valve.The sheath was retracted and advanced again, and it was possible it perforated the left atrial appendage at this time.The hd grid did not move where expected, and it became clear during mapping that it was in the pericardial space.An effusion was identified via transthoracic echocardiography, a pericardiocentesis was performed on the table and the patient was prepped for surgery to repair the perforation from the sheath.The bleeding later stabilized, and no surgery was needed.The patient died overnight from pulseless electrical activity.There were no performance issues with any abbott device.

Event Description

Related mfr number: 3005334138-2020-00589.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1, 63 CM LENGTH, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10988260
• MDR Text Key: 220817372
• Report Number: 3005334138-2020-00581
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205771
• UDI-Public: (01)05414734205771(10)7545008(17)230531
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 407453
• Device Catalogue Number: 407453
• Device Lot Number: 7545008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR HD GRID CATHETER, SENSOR ENABLED
• Patient Outcome(s): Death; Other