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

Model Number 131F7

Device Problem Failure to Deflate (4060)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2021

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12134493
• MDR Text Key: 260478652
• Report Number: 12134493
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405(17)221130(11)201130(10)63543985
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7
• Device Catalogue Number: 131F7P
• Device Lot Number: 63543985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32120 DA
• Patient Weight: 63