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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complete Heart Block (2627); Vascular Dissection (3160)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported dissection and heart block could not be conclusively determined.

Event Description

Related manufacturing reference: 3005334138-2019-00282.During an ventricular tachycardia ablation procedure an aortic dissection and heart block occurred.During the procedure the advisor hd grid catheter was used to map the left ventricle (lv).When the ablation target was defined the user attempted to insert the ablation catheter through the left branch but could not get the catheter to progress through the aorta.A dissection was suspected in the aorta and a different branch was used to reach the target ablation site and continue the procedure.No intervention was needed for the dissection.Additionally a heart block occurred, the right branch did not have conduction from the atrium to the ventricle and the left branch was blocked by the advisor catheter.The procedure was completed with a temporary pacemaker.There were no performance issues with any abbott 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: 8657859
• MDR Text Key: 146628124
• Report Number: 3005334138-2019-00283
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/31/2019

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 Model Number: D-AVHD-DF16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 05/31/2019
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FLEXABILITY¿ ABLATION CATHETER
• Patient Outcome(s): Other