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

Model Number D97120F5

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

Mid 80¿s male with history of severe aortic stenosis.Procedure: transcatheter aortic valve replacement (tavr).When the edwards balloon tip pacer was used, it was observed that the balloon had a whole in it, it did not function.It was removed and another was used without difficulty.No known harm to patient, discharged the next day.Manufacturer response for catheter, flow directed, swan-ganz (per site reporter).Will obtain.

• 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: 15843025
• MDR Text Key: 304098645
• Report Number: 15843025
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 64520444
• 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: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Sex: Male
• Patient Weight: 65 KG