MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN GANZ; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Lot Number 60882230

Device Problem Inflation Problem (1310)

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

Event Date 12/18/2017

Event Type  malfunction  

Event Description

Balloon did not inflate during testing, it was never inserted into patient.A new one was used and worked fine.Lot number: 60910413.

• Brand Name: SWAN GANZ
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7181950
• MDR Text Key: 96963442
• Report Number: 7181950
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/24/2019
• Device Lot Number: 60882230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO