MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN GANZ CATHETER CATH ART 7.5FR 110CM 5 LUM TD W/O HEPARIN SG STD L; CATHETER, FLOW DIRECTED

Catalog Number 831F75P

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Event Description

The swan ganz catheter was noted to have a metal fleck on the catheter that appeared to be embedded in the plastic.No harm.Diagnosis or reason for use: hemodynamic monitoring during surgery.

• Brand Name: SWAN GANZ CATHETER CATH ART 7.5FR 110CM 5 LUM TD W/O HEPARIN SG STD L
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 8343695
• MDR Text Key: 137122399
• Report Number: MW5084117
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 831F75P
• Device Lot Number: 61553555
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1