MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, CONTINUOUS FLUSH

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/04/2022

Event Type  malfunction  

Event Description

Three pronged brown cable connection port off of 7.5 f swan ganz catheter was found to have blood leaking out of it.The blood was leaking out very slowly around the three gold prongs.Noted that this surgery was very complex with need for placement onto rvad with oxygenator, addressing lung bleb in addition to cardiac procedure and patient left with open chest.Pt arrived post-op to cvicu with pa catheter noted to be leaking/backing up blood - kept in place, but nursing then not "shooting numbers" (not doing thermodilution measuring of cardiac output & index which would be typical in this type of patient).Noted that in insertion note by dr., the following was stated: "pulmonary artery catheterization right subclavian vein.¿ the patient experienced the following events during the procedure: unable to pass to pa due to tr, left in rv.Unclear if any of these procedural factors also contributed to leaking/blood backing up or if this is purely a device malfunction separate from any insertion or procedural factors.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 15485084
• MDR Text Key: 300575972
• Report Number: 15485084
• Device Sequence Number: 1
• Product Code: KRA
• 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: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: Black Or African American