MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ DIAGNOSTIC CATHETER, MEDIGUIDE ENABLED,¿; ELECTRODE RECORDING CATHETER

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

Patient Problem Vascular Dissection (3160)

Event Date 08/18/2022

Event Type  Injury  

Event Description

During a crtd implant (for the lv lead placement), a dissection occurred at the coronary sinus ostium with the catheter.There were no hemodynamic consequences for the patient and the procedure was successfully completed.No intervention was needed.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported dissection could not be conclusively determined.

• Brand Name: LIVEWIRE¿ DIAGNOSTIC CATHETER, MEDIGUIDE ENABLED,¿
• Type of Device: ELECTRODE RECORDING CATHETER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15302685
• MDR Text Key: 298699721
• Report Number: 2182269-2022-00035
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1