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

Model Number	C146F7
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of coronary heart disease, hypertension, recent chest pressure and shortness of breath was admitted for a right/left heart catheterization with angioplasty.The latex free swan balloon of the swan-ganz pulmonary artery catheter would not stay inflated.The swan-ganz pulmonary artery catheter was removed from patient without known harm, and a different one was used without problems.

• Brand Name: SWAN-GANZ CONTROLCATH
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12452498
• Report Number: 12452498
• Device Sequence Number: 17134793
• Product Code: DYG
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)230312(11)210312(10)63662593
• 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): 08/30/2021
• Report Date (Section F): 08/30/2021

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: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 63662593
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74
• Date Report Sent to FDA: 08/30/2021