MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),; CATHETER, STEERABLE

Model Number 401932

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

Patient Problem Vascular Dissection (3160)

Event Date 07/22/2019

Event Type  Injury  

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 dissection could not be conclusively determined.

Event Description

Related manufacturing reference: 3008452825-2019-00404, 3008452825-2019-00405, 3008452825-2019-00407.During an atrial fibrillation and atrial flutter ablation procedure a dissection occurred.During the procedure, as the physician was guiding the devices through a narrow left iliac vein, the patient became hypotensive.A hemoglobin test was run and it was determined the patient needed a blood transfusion.Contrast was injected to determine the location of the bleeding and a dissection was found.Vascular intervention was not required as the dissection closed on its own.The procedure was completed and the patient was stable.There were no performance issues with any abbott device.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),
• 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: 8883686
• MDR Text Key: 153977207
• Report Number: 2182269-2019-00113
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202626
• UDI-Public: 05414734202626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913940
• 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
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 401932
• Device Catalogue Number: 401932
• Device Lot Number: 6874133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• 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: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER X2; VIEWFLEX¿ XTRA ICE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 76