MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, OXIMETER, FIBEROPTIC

Catalog Number C146F7

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 03/05/2016

Event Type  malfunction  

Event Description

During an emergent left and right heart catheterization procedure, doctor inserted a latex-free swan catheter through the patient's right femoral vein.Under fluoroscopy, doctor noticed that the balloon had a leak.The swan catheter was immediately removed from the patient and sequestered.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine, CA 92614
• MDR Report Key: 5519291
• MDR Text Key: 40964428
• Report Number: 5519291
• Device Sequence Number: 1
• Product Code: DQE
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/16/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/27/2017
• Device Catalogue Number: C146F7
• Device Lot Number: 60162023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2016
• Event Location: Other
• Date Report to Manufacturer: 03/16/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR