MAUDE Adverse Event Report: EDWARD LIFESCIENCES LLC SWAN GANZ; THERMODILUTION SWAN GANZ CATHETER

Model Number 131F7

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Event Description

During right heart cath, the doctor noticed that the pressure reading from distal port did not correlate with swan position based on fluoro.Catheter was removed and inspected and distal port was connected to proximal lumen.No harm to patient.

• Brand Name: SWAN GANZ
• Type of Device: THERMODILUTION SWAN GANZ CATHETER
• Manufacturer (Section D): EDWARD LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7595807
• MDR Text Key: 110895658
• Report Number: 7595807
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018,05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/21/2019
• Device Model Number: 131F7
• Device Catalogue Number: NOT AVAILABLE
• Device Lot Number: 61176373
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1