MAUDE Adverse Event Report: EDWARDS LIFESCIENCE, LLC. SWAN GANZ; CATHETER, FLOW DIRECTED

Lot Number 60103484

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2015

Event Type  malfunction  

Event Description

While preparing equipment for a right/left heart catheterization.We were testing the swanganz catheter's balloon prior to start of procedure and found the balloon defective.

• Brand Name: SWAN GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCE, LLC.; one edwards way; irvine CA 92614
• MDR Report Key: 5167876
• MDR Text Key: 28915468
• Report Number: 5167876
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Lot Number: 60103484
• Other Device ID Number: 111F7/127360
• 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: 09/29/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• 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
• Patient Age: 85 YR
• Patient Weight: 60