MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ VIP; PULMONARY ARTERY CATHETER

Model Number 831F75

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2017

Event Type  malfunction  

Event Description

Doctor was performing a right and left heart catheterization on the patient.While inserting a swan catheter, doctor was unable to inflate the balloon at the tip of the catheter which aids in proper insertion.Another swan catheter was opened and placed on the sterile table, then tested for balloon inflation.That balloon would not inflate.A third swan catheter was inserted in order to complete the procedure.No apparent injury to the patient.

• Brand Name: SWAN-GANZ VIP
• Type of Device: PULMONARY ARTERY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 6653058
• MDR Text Key: 77939138
• Report Number: 6653058
• 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: Other
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 831F75
• Device Catalogue Number: 831F75
• Device Lot Number: 60615442 X 2EA/ 1 EA 6065187
• 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: 06/15/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• 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: 71 YR