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

Model Number 131F7

Device Problem Failure to Deflate (4060)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

Middle-aged male with history of severe aortic insufficiency and stenosis.Procedure: elective right and left heart cath.Issue- before using the swan, the balloon was inflated, and it would not deflate.Not used on patient.Manufacturer response for swan-ganz, swan-ganz (per site reporter).Will obtain.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 17170209
• MDR Text Key: 317557218
• Report Number: 17170209
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: 131F7
• Device Lot Number: 64964003
• 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: 06/06/2023
• Date Report to Manufacturer: 06/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Male
• Patient Weight: 111 KG