MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ VIP+; CATHETER, FLOW DIRECTED

Model Number 834F75

Device Problems Material Fragmentation (1261); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 01/31/2020

Event Type  Injury  

Event Description

Nurse in cardiovascular intensive care unit (cvicu) attempted to pull swan ganz catheter at order of nurse practitioner.The nurse met resistance and stopped pulling catheter, replaced dressing, and notified nurse practitioner.The physician was notified.A chest x-ray was performed.The patient was taken back to operating room for fragment to be removed.The physician located the fragment at juncture of superior vena cava and right atrium.Fragment removed without difficulty.Patient returned to cvicu post procedure.

• Brand Name: SWAN-GANZ VIP+
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 9693290
• MDR Text Key: 178574302
• Report Number: 9693290
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 834F75
• Device Catalogue Number: 834F75
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 16060 DA