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

Model Number 777F8

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

An elderly male in or for minimally invasive mitral valve replacement.During the first attempt of floating swan, it was noted that the swan would not pick up to pulmonary artery (pa) pressure and there was some discontinuity in pressure transduction apparatus.Anesthesia attempted to refloat swan, change scale setting and still no pa pressure was shown.A 2nd swan was opened to field, and it worked correctly, and all pressures were displayed.No patient harms.Additional time for change-out during anesthesia was minimal.

• Brand Name: SWAN-GANZ CCOMBO V
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 15592617
• MDR Text Key: 301630341
• Report Number: 15592617
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64320628
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Race: White