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

Model Number 831F75

Device Problems Deflation Problem (1149); Material Rupture (1546)

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

Event Date 07/10/2015

Event Type  malfunction  

Event Description

An edwards vip swan ganz catheter was in the left ij cordis.After wedge was performed, the syringe did not deflate and release air.Then the syringe was pulled back on to ensure the balloon was deflated and blood return was noted in syringe.The swan ganz catheter was removed and balloon rupture was noted.

• Brand Name: SWAN-GANZ CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC; one edwards way; irvine, CA 92614
• MDR Report Key: 5010560
• MDR Text Key: 23268328
• Report Number: 5010560
• 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: Other
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 831F75
• Device Lot Number: 59757969
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2015
• Device Age: 2 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• 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