MAUDE Adverse Event Report: PIGTAIL CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Ventricular Fibrillation (2130); Respiratory Arrest (4461)

Event Type  Death  

Event Description

It was reported that a patient death occurred.The laa was accessed with a pigtail catheter.The echocardiogram physician made a note of the patient's blood pressure.The wds was recaptured.During recapture, the physician encountered difficulty keeping the core wire stable while advancing the sheath over the face and shoulders of the closure device.Approximately one-hour post-procedure, the patient became short of breath and was reintubated.The patient decompensated, experiencing cardiac arrest with pulseless electrical activity for 30 minutes followed by ventricular fibrillation and shock.Despite efforts, the patient died.The official cause of death was cardiac arrest.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PIGTAIL CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 18712000
• MDR Text Key: 335565971
• Report Number: MW5151687
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death