MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL FLOW DIRECTED PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 401763

Device Problems Intermittent Capture (1080); Pacing Problem (1439)

Patient Problems Cardiac Arrest (1762); Asystole (4442)

Event Date 02/14/2023

Event Type  Injury  

Event Description

The catheter was left inside the patient following a tavr procedure and the patient coded, was intubated and is now recovering.The catheter was going to be inserted with the expectation of leaving the catheter in the patient.Pre procedure, the catheter was floated into the rv vein via inguinal jugular access.During the procedure, rapid pace is set at 180-200 bpm during valve deployment and intermittent beats occurred.Troubleshooting was done which did not resolve the issue.The procedure was completed successfully and the patient was brought to the unit.A couple hours later, the device was still pacing.Approximately an hour later, the patient went into asystole, the device lost capture and the patient coded and was intubated.The patient was recovering as of (b)(6) 2023.

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 pacing issue and cardiac arrest remains unknown.

• Brand Name: PACEL FLOW DIRECTED PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16408707
• MDR Text Key: 309874027
• Report Number: 2182269-2023-00010
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401763
• Device Catalogue Number: 401763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 99 YR
• Patient Sex: Female
• Patient Weight: 81 KG