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

Model Number D97120F5

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Extravasation (1842)

Event Date 02/25/2022

Event Type  malfunction  

Event Description

Right brachial swan catheter was placed in the cath lab with introducer.Levophed and vasopressin infused via the introducer side port.This is only 11 inches long and when in the brachial vein this is less than a mid line catheter and is not considered a central line.More consistent with a peripheral iv.Line placed and three days later, the bedside rn switched the medications infusing from the side port to the cvp (blue port of the swan) so that medication delivery would be central.Later discontinued swan and obtained picc.Root cause of event determined to be knowledge gap for introducers location is not a central catheter and vesicant medications infusing for longer length of time.This event resulted in extravasation injury to the patient's right upper arm.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 13927980
• MDR Text Key: 288044604
• Report Number: 13927980
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: 00690103150421
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2022,03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26645 DA
• Patient Weight: 28 KG