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

Model Number C146F7

Device Problem Inflation Problem (1310)

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

Event Date 05/13/2019

Event Type  malfunction  

Event Description

The balloon would not stay inflated after the catheter was inserted into the pulmonary artery.Staff had to remove the catheter and use a new one.No harm to pt.(b)(4).

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; irvine CA 92614
• MDR Report Key: 8624547
• MDR Text Key: 145738444
• Report Number: MW5086754
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 61398017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR