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

Model Number	131F7
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of acute renal failure on chronic renal failure stage iv, severe aortic stenosis, congestive heart failure, diabetes mellitus and hypertension was admitted for a right and left coronary angiography and right heart catheterization.During surgical preparation of the swan-ganz pulmonary artery balloon catheter, the balloon would not deflate.The faulty device was not used on the patient.

• Brand Name: SWAN-GANZ
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12134493
• Report Number: 12134493
• Device Sequence Number: 11953463
• Product Code: DYG
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405(17)221130(11)201130(10)63543985
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/23/2021
• Report Date (Section F): 06/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 131F7
• Device Catalogue Number: 131F7P
• Device Lot Number: 63543985
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 63
• Date Report Sent to FDA: 06/23/2021