MAUDE Adverse Event Report: EDWARDS LIFE SCIENCE, LLC SWAN PULMONARY BALLOON CATHETER TD; CATHETER, FLOW DIRECTED

Catalog Number 131HF7

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/01/2014

Event Type  No Answer Provided  

Event Description

The respiratory therapist checked the device prior to use.The themodilution swan did not work properly because it was missing a gold pin on the device, therefore, it was not used.

• Brand Name: SWAN PULMONARY BALLOON CATHETER TD
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFE SCIENCE, LLC; one edwards way; irvine CA 92614
• MDR Report Key: 4340472
• MDR Text Key: 16632948
• Report Number: 4340472
• Device Sequence Number: 1
• Product Code: DQE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Health Professional
• Device Catalogue Number: 131HF7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 67