MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE

Model Number 401575

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

Patient Problem Cardiac Perforation (2513)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2030404-2020-00012, 3008452825-2020-00112, 2182269-2020-00020, 2182269-2020-00021, 3008452825-2020-00113, 2030404-2020-00013, 3005334138-2020-00072.During a pulmonary vein isolation ablation procedure, a pericardial effusion occurred.After the procedure was completed, the patient became hypotensive, so an ultrasound was performed, confirming a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.

Manufacturer Narrative

One 6f, decapolar, medium sweep, livewire ep catheter was received for evaluation.No visual or function issues were noted.Electrodes 1-10 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported cardiac perforation cannot be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9744997
• MDR Text Key: 182759880
• Report Number: 2182269-2020-00022
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202183
• UDI-Public: 05414734202183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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
• Device Expiration Date: 10/31/2022
• Device Model Number: 401575
• Device Catalogue Number: 401575
• Device Lot Number: 7267714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82