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

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 07/11/2023

Event Type  Death  

Event Description

The report comes from dr.(b)(6) in concerning a 7fr swan ganz catheter manufactured by: edwards please see event description below for more details: it was reported that during the right heart catheterization procedure prior to cardiomems implant the physician perforated the patient's pulmonary artery while inflating the balloon of the edwards catheter.This took place before anything pertaining to the cardiomems portion of the procedure was started.The procedure was abandoned.Coiling was used but was not successful in treating the perforation and the patient died.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Refer to add'l documents in i2k.

• Brand Name: SWAN-GANZ CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC.
• MDR Report Key: 18358557
• MDR Text Key: 331047229
• Report Number: MW5149379
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death