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

Patient Problem Pericardial Effusion (3271)

Event Type  Injury  

Event Description

It was reported that a pigtail catheter was inserted, 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 patient is still in the hospital.A pe (pulmonary embolism) was noticed prior to the procedure, a small one (around 1cm) pe that i believe was around the inferior portion of the left ventricle, and before tapping it was noticed a pe in the same place around 3cm.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: 18720897
• MDR Text Key: 335733188
• Report Number: MW5151740
• 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