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

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

Patient Problems Death (1802); Embolism (1829); Myocardial Infarction (1969)

Event Date 09/22/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing ref: 3008452825-2020-00534, 3005334138-2020-00481.During a ventricular tachycardia (vt) / left ventricle (lv) substrate ablation procedure, the patient expired.The patient became hypotensive during the procedure and there was no movement of the lv wall.An intracardiac echocardiography confirmed there was no effusion present.Hypotensive medication was administered, and cardiopulmonary resuscitation was started.The lv was structurally intact as confirmed by transesophageal echocardiogram (tee).The lv wall motion never resumed, cpr continued for 30-40 minutes; however, the patient expired.The physician stated that a clot most likely traveled down the coronary resulting in a myocardial infarction during procedure.There were no performance issues with any abbott devices.

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 hypotension and subsequent death may have been due to a clot that traveled down the coronary resulting in a myocardial infarction during procedure.

• 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
• MDR Report Key: 10643114
• MDR Text Key: 210235941
• Report Number: 3005334138-2020-00480
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/11/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS¿ INTRODUCER; TACTICATH¿ ABLATION CATHETER, SE; AGILIS¿ INTRODUCER; TACTICATH¿ ABLATION CATHETER, SE
• Patient Outcome(s): Death
• Patient Age: 78 YR