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 03/14/2019

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing ref: 9680001-2019-00052, 2182269-2019-00034, 3005334138-2019-00175.During a premature ventricular contraction ablation procedure, a pericardial tamponade occurred and the patient expired.Following geometry creation, ablation was performed in the left pulmonary veins (pv) and the patient became hypotensive.An ultrasound was performed, and ablation continued in the right pv spontaneous induction from an atrial tachycardia.The decision was made to ablate an anterior block line and the patient became hypotensive again and an ultrasound revealed a pericardial tamponade.A pericardiocentesis was performed, however, the blood pressure did not increase and cardiopulmonary resuscitation (cpr) was started.After one hour of cpr without any improvement, cpr was stopped, and the patient expired.There were no performance issues with any abbott devices.The patient expired due to electrical mechanical decoupling caused by pericardial tamponade during ablation of a left atrial flutter.

Event Description

During a pulmonary vein isolation ablation procedure.

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.

• 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
• 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: 8465805
• MDR Text Key: 140345758
• Report Number: 3005334138-2019-00174
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205771
• UDI-Public: 05414734205771
• 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,Followup,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 407453
• Device Lot Number: 6838421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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: ADVISOR CATHETER; AGILIS INTRODUCER; TACTICATH ABLATION CATHETER
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Weight: 85