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

Model Number D97130F5

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2020

Event Type  malfunction  

Event Description

An elderly female with history of hypertension, coronary artery disease and severe aortic stenosis.While prepping the swan for a transcatheter aortic valve replacement, the balloon would not inflate.Not used for the procedure.Another report was issued with the same problem and the same lot #.See 3600840000-2021-8008.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11154235
• MDR Text Key: 226297798
• Report Number: 11154235
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• Device Lot Number: 63412882
• 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: 01/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Weight: 61