MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-AVHD-DF16

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis (2100)

Event Date 05/28/2020

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 thrombolytic event was due to low act levels during the procedure.

Event Description

Following an atrial fibrillation procedure, a thrombolytic event occurred.The ablation procedure was successfully carried out on may 28th with no anomalies.The following day, the patient exhibited a speech issue believed to be due to thrombus formation on the hd grid.The device was irrigated with 1 l of saline solution and 5000 units of heparin were added prior to insertion into the left atrium.No irrigation issues were observed during the ablation procedure.After removing the catheter, the physician observed a small amount of coagulum between the splines of the hd grid catheter.During the procedure, the patient's act level did not exceed 270.The physician believes the low act level was the likely cause of the coagulum on the catheter and subsequent thrombolytic event.The patient fully recovered and is in stable condition.There were no performance issues with the device.

• Brand Name: ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 10133939
• MDR Text Key: 194508320
• Report Number: 3005334138-2020-00230
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172393
• 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
• Report Date: 06/09/2020

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: 11/30/2022
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 7307199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• 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): Other