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

Model Number 931F75

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2019

Event Type  malfunction  

Event Description

Blood was seeping from one of the pulmonary artery (pa) catheter's port.This was not the purpose of that port, and no blood should have come from it.

• Brand Name: SWAN-GANZ PACEPORT
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10137442
• MDR Text Key: 194624232
• Report Number: 10137442
• 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: 06/05/2020,07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 931F75
• Device Catalogue Number: 931F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA