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

Model Number 131F7

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

Patient with recurrent admissions for acute on chronic systolic heart failure, reduced ejection fraction and cardiomyopathy had a scheduled right heart catheterization.During procedure, a swan-ganz td 7f catheter balloon did not inflate.Second 7f catheter was used to finish with the procedure.Patient tolerated procedure with no complications.

• 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: 18977463
• MDR Text Key: 338576380
• Report Number: 18977463
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 131F7
• Device Catalogue Number: 131F7P
• 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: 01/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White