MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F; INTRODUCER, CATHETER

Model Number 407451

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

Patient Problems Arrhythmia (1721); Death (1802); Respiratory Failure (2484)

Event Date 01/08/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event were requested but not received.

Event Description

Related manufacturer reference: 3008452825-2020-00015, 3005334138-2020-00019, 3008452825-2020-00016, 3008452825-2020-00017, 3008452825-2020-00018, 3008452825-2020-00019, 3005334138-2020-00020.During the mapping of a ventricular tachycardia ablation procedure, following mapping of the right and left ventricle, the patient experienced respiratory failure and pulseless electrical activity.An immediate cardiac massage was performed, without the restoration of natural heart contraction.There was no pericardial effusion visible with the intracardiac echo and the procedure was interrupted before the ablation.The patient expired.The cause of the respiratory failure and subsequent death is unknown.There were no performance issues with any abbott device.

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 respiratory failure and subsequent death could not be conclusively determined.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9590556
• MDR Text Key: 175024317
• Report Number: 3005334138-2020-00021
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205757
• UDI-Public: 05414734205757
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 407451
• Device Catalogue Number: 407451
• Device Lot Number: 6940001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR¿ HD GRID MAPPING CATHETER, SE; BRK-1¿ XS TRANSSEPTAL NEEDLE; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER (X2); VIEWFLEX¿ XTRA ICE CATHETER; ADVISOR¿ HD GRID MAPPING CATHETER, SE; BRK-1¿ XS TRANSSEPTAL NEEDLE; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER (X2); VIEWFLEX¿ XTRA ICE CATHETER
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 48