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 Arrhythmia (1721); Death (1802); Respiratory Failure (2484)

Event Date 01/08/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference: 3008452825-2020-00015, 3008452825-2020-00016, 3008452825-2020-00017, 3008452825-2020-00018, 3008452825-2020-00019, 3005334138-2020-00020, 3005334138-2020-00021.During the mapping of a ventricular tachycardia ablation procedure, following mapping of the right and left ventricle, the patient experienced respiratory failure and pulseless electrical activity.An immediate cardiac massage was performed, without the restoration of natural heart contraction.There was no pericardial effusion visible with the intracardiac echo and the procedure was interrupted before the ablation.The patient expired.The cause of the respiratory failure and subsequent death is unknown.There were no performance issues with any abbott device.

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 respiratory failure and subsequent death could not be conclusively determined.

• 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 (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9590517
• MDR Text Key: 175022878
• Report Number: 3005334138-2020-00019
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 02/17/2020

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: 08/31/2022
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 7185826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• 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: BRK-1¿ XS TRANSSEPTAL NEEDLE; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER (X2); SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; VIEWFLEX¿ XTRA ICE CATHETER
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 48