MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 139F75

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  malfunction  

Event Description

Swan-ganz catheter defective.Rn unable to remove connection at hub.Entire catheter and cordis had to be removed at once.Patient remained stable.No adverse effects noted.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 8669768
• MDR Text Key: 147027917
• Report Number: 8669768
• Device Sequence Number: 1
• Product Code: DQO
• 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: 05/21/2019,05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 139F75
• Device Catalogue Number: 139F75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2019
• Date Report to Manufacturer: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA