MAUDE Adverse Event Report: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271); Respiratory Arrest (4461)

Event Type  Injury  

Event Description

It was reported that a perforation, a pericardial effusion, and a cardiac tamponade occurred.The procedure was aborted.During procedure, the right femoral was accessed, right before inserting the pigtail catheter, the patient had moved and made the physician note on fluoro the sheath going near the heart outline.Then, once the pigtail catheter was going up, the tee lmager scanned over to appendage where it was noticed more fluid in the transverse sinus cavity than before.Thus, upon the effusion sweep, it has been noticed there was around the same effusion as the baseline effusion recorded before, behind left atrium.Once checking for the patient's pressure from anesthesia, it has been mentioned that it was not being possible to get a proper pressure reading since the start of the case.While the staff was trying to hook up a blood pressure cuff to the patient's leg, the pericardial effusion size get larger on tee.The physician called a code blue and started chest compressions.Once the patient was back in normal rhythm, the patient was transferred to cardiovascular intensive care unit (cvicu) to stay the night.A pericardial effusion was noted prior to the procedure (measuring about 1 cm), but the cause is unknown.The pe get larger before tapping it off (measuring about 3cm).The patient is still in the hospital.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 18720931
• MDR Text Key: 335733409
• Report Number: MW5151741
• 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: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1