MAUDE Adverse Event Report: MEDTRONIC VASCULAR PULMONARY WEDGE PRESSURE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 150075

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Pain (1994); Pericardial Effusion (3271)

Event Date 09/19/2021

Event Type  Injury  

Event Description

Following successful implantation of cardiomems device, it was found that the right ventricle had been perforatedand the patient had pericardial effusion.Following the implant procedure, the patient began complaining of back pain and chest pain and her blood pressure began to drop.A ct scan and echo were performed and the pericardialeffusion was identified.A pericardiocentesis procedure was performed to drain the effusion.Patient was brought to intensive care unit for monitoring but remained unstable so was brought for open heart surgery to assess/repair source of pericardial effusion.Surgeon found and successfully repaired perforation injury in the right ventricle.Physician reported that he could not confirm if the wedge catheter or guidewire (both non-abbott devices: pulmonary wedge pressure catheter (medtronic), 7f, ref #150075 lot #0011311390) caused the perforation but stated that due to the location in the right ventricle he believes it was not caused by the cardiomems device.Patient is recovering from the surgery.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULMONARY WEDGE PRESSURE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 17531451
• MDR Text Key: 321137490
• Report Number: MW5138366
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 150075
• Device Lot Number: 11311390
• Patient Sequence Number: 1