MAUDE Adverse Event Report: BARD G2X/ECLIPSE TEMPORARY FILTER

Device Problem Break (1069)

Patient Problems Cardiac Arrest (1762); Foreign Body In Patient (2687)

Event Date 05/06/2017

Event Type  Injury  

Event Description

Pt with g2x or eclipse ivcf presented with what was thought to be acute coronary syndrome.During course of hospitalization, pt arrested and underwent chest compressions.Fragment of broken filter found to be in pericardium/poking into rv with large hemopericardium; pt underwent sternotomy and removal of fragment with pericardial window, is now recovering.Filter to be removed today.Another fragment is in rul pulmonary artery and may be removed in a separate procedure.In retrospect it may be that the entire episode was due to the pericardial fragment.Of note, imaging showed the fragments to be in the heart and lung before the code/chest compressions.Operating surgeon was dr.(b)(6).

• Brand Name: G2X/ECLIPSE TEMPORARY FILTER
• Type of Device: TEMPORARY FILTER
• Manufacturer (Section D): BARD; tempe
• MDR Report Key: 6556911
• MDR Text Key: 74935684
• Report Number: MW5069664
• Device Sequence Number: 1
• Product Code: DTK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: EXPLANTED: ; PERICARDIAL FRAGMENT - IMPLANTED:
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 47 YR
• Patient Weight: 68